Delivery systems with telescoping capsules for deploying prosthetic heart valve devices and associated methods

ABSTRACT

Delivery systems with telescoping capsules for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, a delivery capsule having a first housing, a second housing slidably disposed within a portion of the first housing, and a prosthetic device constrained within the first and second housings. The delivery capsule can further include first and second chamber defined in part by the first and second housings. During deployment, fluid is delivered to the first chamber to move the first housing distally over the second housing, thereby releasing a portion of the prosthetic device. Subsequently, fluid is delivered to the second chamber such that the first and second housings move together in the distal direction to release a second portion of the prosthetic device.

This application is a continuation of U.S. patent application Ser. No.15/611,823, filed on Jun. 2, 2017, the entire content of which isincorporated by reference herein.

TECHNICAL FIELD

The present technology relates generally to systems for deliveringprosthetic heart valve devices. In particular, several embodiments ofthe present technology are related to delivery systems with telescopingcapsules for percutaneously delivering prosthetic heart valve devicesand associated methods.

BACKGROUND

Heart valves can be affected by several conditions. For example, mitralvalves can be affected by mitral valve regurgitation, mitral valveprolapse and mitral valve stenosis. Mitral valve regurgitation isabnormal leaking of blood from the left ventricle into the left atriumcaused by a disorder of the heart in which the leaflets of the mitralvalve fail to coapt into apposition at peak contraction pressures. Themitral valve leaflets may not coapt sufficiently because heart diseasesoften cause dilation of the heart muscle, which in turn enlarges thenative mitral valve annulus to the extent that the leaflets do not coaptduring systole. Abnormal backflow can also occur when the papillarymuscles are functionally compromised due to ischemia or otherconditions. More specifically, as the left ventricle contracts duringsystole, the affected papillary muscles do not contract sufficiently toeffect proper closure of the leaflets.

Mitral valve prolapse is a condition when the mitral leaflets bulgeabnormally up in to the left atrium. This can cause irregular behaviorof the mitral valve and lead to mitral valve regurgitation. The leafletsmay prolapse and fail to coapt because the tendons connecting thepapillary muscles to the inferior side of the mitral valve leaflets(chordae tendineae) may tear or stretch. Mitral valve stenosis is anarrowing of the mitral valve orifice that impedes filling of the leftventricle in diastole.

Mitral valve regurgitation is often treated using diuretics and/orvasodilators to reduce the amount of blood flowing back into the leftatrium. Surgical approaches (open and intravascular) for either therepair or replacement of the valve have also been used to treat mitralvalve regurgitation. For example, typical repair techniques involvecinching or resecting portions of the dilated annulus. Cinching, forexample, includes implanting annular or peri-annular rings that aregenerally secured to the annulus or surrounding tissue. Other repairprocedures suture or clip the valve leaflets into partial appositionwith one another.

Alternatively, more invasive procedures replace the entire valve itselfby implanting mechanical valves or biological tissue into the heart inplace of the native mitral valve. These invasive proceduresconventionally require large open thoracotomies and are thus verypainful, have significant morbidity, and require long recovery periods.Moreover, with many repair and replacement procedures, the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may cause additional problems for the patient. Repair proceduresalso require a highly skilled cardiac surgeon because poorly orinaccurately placed sutures may affect the success of procedures.

Less invasive approaches to aortic valve replacement have beenimplemented in recent years. Examples of pre-assembled, percutaneousprosthetic valves include, e.g., the CoreValve Revalving® System fromMedtronic/Corevalve Inc. (Irvine, Calif., USA) and the Edwards-Sapien®Valve from Edwards Lifesciences (Irvine, Calif., USA). Both valvesystems include an expandable frame and a tri-leaflet bioprostheticvalve attached to the expandable frame. The aortic valve issubstantially symmetric, circular, and has a muscular annulus. Theexpandable frames in aortic applications have a symmetric, circularshape at the aortic valve annulus to match the native anatomy, but alsobecause tri-leaflet prosthetic valves require circular symmetry forproper coaptation of the prosthetic leaflets. Thus, aortic valve anatomylends itself to an expandable frame housing a replacement valve sincethe aortic valve anatomy is substantially uniform, symmetric, and fairlymuscular. Other heart valve anatomies, however, are not uniform,symmetric or sufficiently muscular, and thus transvascular aortic valvereplacement devises may not be well suited for other types of heartvalves.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent. The headings provided herein are forconvenience only.

FIG. 1 is a schematic, cross-sectional illustration of the heart showingan antegrade approach to the native mitral valve from the venousvasculature in accordance with various embodiments of the presenttechnology.

FIG. 2 is a schematic, cross-sectional illustration of the heart showingaccess through the inter-atrial septum (IAS) maintained by the placementof a guide catheter over a guidewire in accordance with variousembodiments of the present technology.

FIGS. 3 and 4 are schematic, cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature in accordance with variousembodiments of the present technology.

FIG. 5 is a schematic, cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present technology.

FIG. 6 is an isometric view of a delivery system for a prosthetic heartvalve device configured in accordance with an embodiment of the presenttechnology.

FIG. 7A is an enlarged side isometric view of a distal portion of thedelivery system of FIG. 6 configured in accordance with embodiments ofthe present technology.

FIG. 7B is an exploded view of a delivery capsule of the delivery systemof FIG. 7A.

FIGS. 8A-8D are a series of illustrations showing a distal portion ofthe delivery system of FIGS. 6-7B deploying and resheathing a prostheticheart valve device in accordance with embodiments of the presenttechnology.

FIG. 9A is a side isometric view of a distal portion of a deliverysystem configured in accordance with embodiments of the presenttechnology.

FIG. 9B is a side isometric view of a distal portion of a deliverysystem configured in accordance with embodiments of the presenttechnology.

FIG. 10A is a partial cut-away isometric view of a distal portion of adelivery system configured in accordance with a further embodiment ofthe present technology.

FIG. 10B is a cross-sectional view of the distal portion of the deliverysystem of FIG. 10A.

FIGS. 10C and 10D are isometric views of inner housing configurationsfor use with the delivery system of FIGS. 10A and 10B.

FIG. 11A is an isometric view of a distal portion of a delivery systemconfigured in accordance with yet another embodiment of the presenttechnology.

FIG. 11B is a cross-sectional view of the distal portion of the deliverysystem of FIG. 11B.

FIG. 12A is an isometric view of a distal portion of a delivery systemconfigured in accordance with a still further embodiment of the presenttechnology.

FIG. 12B is a cross-sectional view of the distal portion of the deliverysystem of FIG. 12B.

FIG. 13A is a cross-sectional side view and FIG. 13B is a top viewschematically illustrating a prosthetic heart valve device in accordancewith an embodiment of the present technology.

FIGS. 14A and 14B are cross-sectional side views schematicallyillustrating aspects of delivering a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 15 is a top isometric view of a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 16 is a side view and FIG. 17 is a bottom isometric view of theprosthetic heart valve device of FIG. 15.

FIG. 18 is a side view and FIG. 19 is a bottom isometric view of aprosthetic heart valve device in accordance with an embodiment of thepresent technology.

FIG. 20 is a side view and FIG. 21 is a bottom isometric view of theprosthetic heart valve device of FIGS. 18 and 19 at a partially deployedstate with respect to a delivery device.

FIG. 22 is an isometric view of a valve support for use with prostheticheart valve devices in accordance with the present technology.

FIGS. 23 and 24 are side and bottom isometric views, respectively, of aprosthetic heart valve attached to the valve support of FIG. 22.

FIGS. 25 and 26 are side views schematically showing valve supports inaccordance with additional embodiments of the present technology.

DETAILED DESCRIPTION

The present technology is generally directed to delivery systems withtelescoping capsules for deploying prosthetic heart valve devices andassociated methods. Specific details of several embodiments of thepresent technology are described herein with reference to FIGS. 1-26.Although many of the embodiments are described with respect to devices,systems, and methods for delivering prosthetic heart valve devices to anative mitral valve, other applications and other embodiments inaddition to those described herein are within the scope of the presenttechnology. For example, at least some embodiments of the presenttechnology may be useful for delivering prosthetics to other valves,such as the tricuspid valve or the aortic valve. It should be noted thatother embodiments in addition to those disclosed herein are within thescope of the present technology. Further, embodiments of the presenttechnology can have different configurations, components, and/orprocedures than those shown or described herein. Moreover, a person ofordinary skill in the art will understand that embodiments of thepresent technology can have configurations, components, and/orprocedures in addition to those shown or described herein and that theseand other embodiments can be without several of the configurations,components, and/or procedures shown or described herein withoutdeviating from the present technology.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can referencerelative positions of portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter). With respect to aprosthetic heart valve device, the terms “proximal” and “distal” canrefer to the location of portions of the device with respect to thedirection of blood flow. For example, proximal can refer to an upstreamposition or a location where blood flows into the device (e.g., inflowregion), and distal can refer to a downstream position or a locationwhere blood flows out of the device (e.g., outflow region).

Overview

Several embodiments of the present technology are directed to deliverysystems and mitral valve replacement devices that address the uniquechallenges of percutaneously replacing native mitral valves and arewell-suited to be recaptured in a percutaneous delivery device afterbeing partially deployed for repositioning or removing the device.Compared to replacing aortic valves, percutaneous mitral valvereplacement faces unique anatomical obstacles that render percutaneousmitral valve replacement significantly more challenging than aorticvalve replacement. First, unlike relatively symmetric and uniform aorticvalves, the mitral valve annulus has a non-circular D-shape orkidney-like shape, with a non-planar, saddle-like geometry often lackingsymmetry. The complex and highly variable anatomy of mitral valves makesit difficult to design a mitral valve prosthesis that conforms well tothe native mitral annulus of specific patients. As a result, theprosthesis may not fit well with the native leaflets and/or annulus,which can leave gaps that allows backflow of blood to occur. Forexample, placement of a cylindrical valve prosthesis in a native mitralvalve may leave gaps in commissural regions of the native valve throughwhich perivalvular leaks may occur.

Current prosthetic valves developed for percutaneous aortic valvereplacement are unsuitable for use in mitral valves. First, many ofthese devices require a direct, structural connection between thestent-like structure that contacts the annulus and/or leaflets and theprosthetic valve. In several devices, the stent posts which support theprosthetic valve also contact the annulus or other surrounding tissue.These types of devices directly transfer the forces exerted by thetissue and blood as the heart contracts to the valve support and theprosthetic leaflets, which in turn distorts the valve support from itsdesired cylindrical shape. This is a concern because most cardiacreplacement devices use tri-leaflet valves, which require asubstantially symmetric, cylindrical support around the prosthetic valvefor proper opening and closing of the three leaflets over years of life.As a result, when these devices are subject to movement and forces fromthe annulus and other surrounding tissues, the prostheses may becompressed and/or distorted causing the prosthetic leaflets tomalfunction. Moreover, a diseased mitral annulus is much larger than anyavailable prosthetic aortic valve. As the size of the valve increases,the forces on the valve leaflets increase dramatically, so simplyincreasing the size of an aortic prosthesis to the size of a dilatedmitral valve annulus would require dramatically thicker, tallerleaflets, and might not be feasible.

In addition to its irregular, complex shape, which changes size over thecourse of each heartbeat, the mitral valve annulus lacks a significantamount of radial support from surrounding tissue. Compared to aorticvalves, which are completely surrounded by fibro-elastic tissue thatprovides sufficient support for anchoring a prosthetic valve, mitralvalves are bound by muscular tissue on the outer wall only. The innerwall of the mitral valve anatomy is bound by a thin vessel wallseparating the mitral valve annulus from the inferior portion of theaortic outflow tract. As a result, significant radial forces on themitral annulus, such as those imparted by an expanding stent prostheses,could lead to collapse of the inferior portion of the aortic tract.Moreover, larger prostheses exert more force and expand to largerdimensions, which exacerbates this problem for mitral valve replacementapplications.

The chordae tendineae of the left ventricle may also present an obstaclein deploying a mitral valve prosthesis. Unlike aortic valves, mitralvalves have a maze of cordage under the leaflets in the left ventriclethat restrict the movement and position of a deployment catheter and thereplacement device during implantation. As a result, deploying,positioning and anchoring a valve replacement device on the ventricularside of the native mitral valve annulus is complicated.

Embodiments of the present technology provide systems, methods andapparatus to treat heart valves of the body, such as the mitral valve,that address the challenges associated with the anatomy of the mitralvalve and provide for repositioning and removal of a partially deployeddevice. The apparatus and methods enable a percutaneous approach using acatheter delivered intravascularly through a vein or artery into theheart, or through a cannula inserted through the heart wall. Forexample, the apparatus and methods are particularly well-suited fortrans-septal and trans-apical approaches, but can also be trans-atrialand direct aortic delivery of a prosthetic replacement valve to a targetlocation in the heart. Additionally, the embodiments of the devices andmethods as described herein can be combined with many known surgeriesand procedures, such as known methods of accessing the valves of theheart (e.g., the mitral valve or triscuspid valve) with antegrade orretrograde approaches, and combinations thereof.

The systems and methods described herein facilitate delivery of aprosthetic heart valve device using trans-septal delivery approaches toa native mitral valve and allow resheathing of the prosthetic heartvalve device after partial deployment of the device to reposition and/orremove the device. The delivery systems can include a telescopingdelivery capsule that has a first housing and a second housing slidablydisposed within at least a portion of the first housing. Duringdeployment, the first housing moves in a distal direction over thesecond housing to release a portion of the prosthetic heart valvedevice, and then the first and second housings move together in a distaldirection to fully deploy the prosthetic heart valve device. Thistelescoping arrangement of the first and second housings requires thedelivery capsule to traverse a short overall longitudinal distancerelative to the device positioned therein for device deployment and,therefore, facilitates deployment within the constraints of nativeanatomy surrounding the mitral valve. In addition, when in the initialdelivery state, the disclosed telescoping delivery capsules can have ashort overall length relative to the length of the prosthetic heartvalve device stored therein, which facilitates delivery along tightlycurved paths necessary to access the native mitral valve viatrans-septal delivery. The disclosed delivery systems can also be usedto delivery other medical devices to other target sites with nativeanatomy that benefits from a compact delivery capsule and reducedlongitudinal translation for deployment.

Access to the Mitral Valve

To better understand the structure and operation of valve replacementdevices in accordance with the present technology, it is helpful tofirst understand approaches for implanting the devices. The mitral valveor other type of atrioventricular valve can be accessed through thepatient's vasculature in a percutaneous manner. By percutaneous it ismeant that a location of the vasculature remote from the heart isaccessed through the skin, typically using a surgical cut down procedureor a minimally invasive procedure, such as using needle access through,for example, the Seldinger technique. The ability to percutaneouslyaccess the remote vasculature is well known and described in the patentand medical literature. Depending on the point of vascular access,access to the mitral valve may be antegrade and may rely on entry intothe left atrium by crossing the inter-atrial septum (e.g., atrans-septal approach). Alternatively, access to the mitral valve can beretrograde where the left ventricle is entered through the aortic valve.Access to the mitral valve may also be achieved using a cannula via atrans-apical approach. Depending on the approach, the interventionaltools and supporting catheter(s) may be advanced to the heartintravascularly and positioned adjacent the target cardiac valve in avariety of manners, as described herein.

FIG. 1 illustrates a stage of a trans-septal approach for implanting avalve replacement device. In a trans-septal approach, access is via theinferior vena cava IVC or superior vena cava SVC, through the rightatrium RA, across the inter-atrial septum IAS, and into the left atriumLA above the mitral valve MV. As shown in FIG. 1, a catheter 1 having aneedle 2 moves from the inferior vena cava IVC into the right atrium RA.Once the catheter 1 reaches the anterior side of the inter-atrial septumIAS, the needle 2 advances so that it penetrates through the septum, forexample at the fossa ovalis FO or the foramen ovale into the left atriumLA. At this point, a guidewire replaces the needle 2 and the catheter 1is withdrawn.

FIG. 2 illustrates a subsequent stage of a trans-septal approach inwhich guidewire 6 and guide catheter 4 pass through the inter-atrialseptum IAS. The guide catheter 4 provides access to the mitral valve forimplanting a valve replacement device in accordance with the technology.

In an alternative antegrade approach (not shown), surgical access may beobtained through an intercostal incision, preferably without removingribs, and a small puncture or incision may be made in the left atrialwall. A guide catheter passes through this puncture or incision directlyinto the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, antegradeapproaches will usually enable more precise and effective centering andstabilization of the guide catheter and/or prosthetic valve device. Theantegrade approach may also reduce the risk of damaging the chordaetendinae or other subvalvular structures with a catheter or otherinterventional tool. Additionally, the antegrade approach may decreaserisks associated with crossing the aortic valve as in retrogradeapproaches. This can be particularly relevant to patients withprosthetic aortic valves, which cannot be crossed at all or withoutsubstantial risk of damage.

FIGS. 3 and 4 show examples of a retrograde approaches to access themitral valve. Access to the mitral valve MV may be achieved from theaortic arch AA, across the aortic valve AV, and into the left ventricleLV below the mitral valve MV. The aortic arch AA may be accessed througha conventional femoral artery access route or through more directapproaches via the brachial artery, axillary artery, radial artery, orcarotid artery. Such access may be achieved with the use of a guidewire6. Once in place, a guide catheter 4 may be tracked over the guidewire6. Alternatively, a surgical approach may be taken through an incisionin the chest, preferably intercostally without removing ribs, andplacing a guide catheter through a puncture in the aorta itself. Theguide catheter 4 affords subsequent access to permit placement of theprosthetic valve device, as described in more detail herein. Retrogradeapproaches advantageously do not need a trans-septal puncture.Cardiologists also more commonly use retrograde approaches, and thusretrograde approaches are more familiar.

FIG. 5 shows a trans-apical approach via a trans-apical puncture. Inthis approach, access to the heart is via a thoracic incision, which canbe a conventional open thoracotomy or sternotomy, or a smallerintercostal or sub-xyphoid incision or puncture. An access cannula isthen placed through a puncture in the wall of the left ventricle at ornear the apex of the heart. The catheters and prosthetic devices of theinvention may then be introduced into the left ventricle through thisaccess cannula. The trans-apical approach provides a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, the trans-apicalapproach does not require training in interventional cardiology toperform the catheterizations required in other percutaneous approaches.

Selected Embodiments of Delivery Systems for Prosthetic Heart ValveDevices

FIG. 6 is an isometric view of a delivery system 100 for a prostheticheart valve device 102 (“device 102”; shown schematically in brokenlines) configured in accordance with an embodiment of the presenttechnology. The delivery system 100 includes a catheter 104 having anelongated catheter body 106 (“catheter body 106”) with a distal portion106 a carrying a delivery capsule 108 and a proximal portion 106 bcoupled to a control unit or handle assembly 110. The delivery capsule108 can move between a containment configuration for holding the device102 in an unexpanded state during delivery of the device 102 and adeployment configuration in which the device 102 is at least partiallyexpanded from the capsule 108. As described in further detail below, thedelivery capsule 108 includes a first housing 112 and a second housing114 slidably disposed within at least a portion of the first housing112. During a first deployment stage, the first housing 112 moves in adistal direction over the second housing 114 to release a first portionof the device 102 from the delivery capsule 108, and during a seconddeployment stage the second housing 114 and the first housing 112 movetogether in a distal direction to release a second portion of the device102 from the delivery capsule 108 (e.g., fully release the device 102from the delivery capsule 108). After partial deployment of the device102, the telescoping delivery capsule 108 can optionally resheathe atleast a portion of the device 102 by urging the first housing 112 and/orthe second housing 114 in a proximal direction back over at least aportion of the device 102. The partial or full resheathing of the device102 allows for repositioning of the device 102 relative to the nativemitral valve after a portion of the device 102 has been expanded andcontacted tissue of the native valve.

The handle assembly 110 can include a control assembly 126 to initiatedeployment of the device 102 from the telescoping delivery capsule 108at the target site. The control assembly 126 may include rotationalelements, buttons, levers, and/or other actuators that allow a clinicianto control rotational position of the delivery capsule 108, as well asthe deployment and/or resheathing mechanisms of the delivery system 100.For example, the illustrated control assembly 126 includes a firstactuator 130 operably coupled to the first housing 112 via the catheterbody 106 to control distal and proximal movement of the first housing112 and a second actuator 132 operably coupled to the second housing 114via the catheter body 106 to control proximal and distal movement of thesecond housing 114. In other embodiments, a single actuator, more thantwo actuators, and/or other features can be used to initiate movement ofthe first and second housings 112 and 114. The handle assembly 110 canalso include a steering mechanism 128 that provides steering capability(e.g., 360 degree rotation of the delivery capsule 108, 180 degreerotation of the delivery capsule 108, 3-axis steering, 2-axis steering,etc.) for delivering the delivery capsule 108 to a target site (e.g., toa native mitral valve). The steering mechanism 128 can be used to steerthe catheter 104 through the anatomy by bending the distal portion 106 aof the catheter body 106 about a transverse axis. In other embodiments,the handle assembly 110 may include additional and/or different featuresthat facilitate delivering the device 102 to the target site. In certainembodiments, the catheter 104 can be configured to travel over aguidewire 124, which can be used to guide the delivery capsule 108 intothe native mitral valve.

As shown in FIG. 6, the system 100 can also include a fluid assembly 116configured to supply fluid to and receive fluid from the catheter 104 tohydraulically move the first and second housings 112 and 114 and therebydeploy the device 102. The fluid assembly 116 includes a fluid source118 and a fluid line 120 fluidically coupling the fluid source 118 tothe catheter 104. The fluid source 118 may include a flowable substance(e.g., water, saline, etc.) contained in one or more reservoirs. Thefluid line 120 can include one or more hoses, tubes, multiple fluidlines within a hose or tube, or other components (e.g., connectors,valves, etc.) through which the flowable substance can pass from thefluid source 118 to the catheter 104 and/or through which the flowablesubstance can drain from the catheter 104 to the fluid source 118. Thefluid assembly 116 can also include one or more pressurization devices(e.g., a pump), fluid connectors, fittings, valves, and/or other fluidiccomponents that facilitate moving the fluid to and/or from the fluidsource 118. As explained in further detail below, the movement of theflowable substance to and from the fluid assembly 116 can be used todeploy the device 102 from the delivery capsule 108 and/or resheathe thedevice 102 after at least partial deployment. In other embodiments,mechanical means, such as tethers and springs, can be used to move thedelivery capsule 108 between the deployment and containmentconfigurations. In further embodiments, both fluidic and mechanicalmeans can initiate deployment and resheathing.

In certain embodiments, the fluid assembly 116 may comprise a controller122 that controls the movement of fluid to and from the catheter 104.The controller 122 can include, without limitation, one or morecomputers, central processing units, processing devices,microprocessors, digital signal processors (DSPs), and/orapplication-specific integrated circuits (ASICs). To store information,for example, the controller 122 can include one or more storageelements, such as volatile memory, non-volatile memory, read-only memory(ROM), and/or random access memory (RAM). The stored information caninclude pumping programs, patient information, and/or other executableprograms. The controller 122 can further include a manual input device(e.g., a keyboard, a touch screen, etc.) and/or an automated inputdevice (e.g., a computer, a data storage device, servers, network,etc.). In still other embodiments, the controller 122 may includedifferent features and/or have a different arrangement for controllingthe flow of fluid into and out of the fluid source 118.

The delivery capsule 108 includes the first housing 112 and the secondhousing 114, which can each contain at least a portion of the device 102in the containment configuration. The second housing 114 can have anopening 134 at its distal end portion through which the guidewire 124can be threaded to allow for guidewire delivery to the target site. Asshown in FIG. 6, the distal end portion of the second housing 114 mayalso have an atraumatic shape (e.g., a partially spherical shape, afrusto-conical shape, blunt configuration, rounded configuration, etc.)to facilitate atraumatic delivery of the delivery capsule 108 to thetarget site. In certain embodiments, the delivery capsule 108 includes aproximal cap 136 that extends proximally from the first housing 112 toseal or enclose the device 102 within the delivery capsule 108. In someembodiments, the proximal cap 136 is omitted and the proximal portion ofthe delivery capsule 108 is left open. In these embodiments, theproximal end portion of the delivery capsule 108 (e.g., the proximal endportion of the first housing 112) can include rounded proximal edges, atapered portion, and/or a soft or pliable material (e.g., a polymer)positioned at the proximal end to facilitate atraumatic retraction ofthe delivery capsule 108 through the body. The first housing 112, thesecond housing 114, and/or the proximal cap 136 can be made of metal(e.g., stainless steel), polymers, plastic, composites, combinationsthereof, and/or other materials capable of holding the device 102 duringtrans-septal and/or trans-apical delivery to the target site (e.g., themitral valve).

As discussed above, the first housing 112 slides or otherwise movesrelative to the second housing 114 in a telescoping manner to release aportion of the device 102 from the delivery capsule 108 and, optionally,resheathe the device 102 after partial deployment. In certainembodiments, the first and second housings 112 and 114 are hydraulicallyactuated via the handle assembly 110 and/or the fluid assembly 116. Inhydraulically-actuated embodiments, the delivery capsule 108 includes afirst fluid chamber configured to receive a flowable material from thefluid assembly 116 to move the first housing 112 relative to the secondhousing 114. The delivery capsule 108 can further include a second fluidchamber configured to receive a flowable material from the fluidassembly 116 to move the first and second housing 112 and 114 as a unit.During the first deployment stage, a clinician can use the firstactuator 130 and/or other suitable control means to deliver fluid (e.g.,water or saline) from the fluid source 118 to the first fluid chamber tomove the first housing 112 in a distal direction over the second housing114 to release a first portion of the device 102 from the deliverycapsule 108. During the second deployment stage, the clinician can usethe second actuator 132 and/or other suitable control means to deliverfluid from the fluid source 118 to the second fluid chamber such thatthe first and second housings 112 and 114 move together in the distaldirection to release a second portion of the device 102 from thedelivery capsule 108 until the device 102 is partially or fullyunsheathed from the delivery capsule 108. The first actuator 130, thesecond actuator 132, and/or other features can also be used to removefluid from the first and second fluid chambers to allow for resheathingof the device 102 or close the delivery capsule 108. In otherembodiments, the first housing 112 and/or the second housing 114 can bemoved distally and proximally for unsheathing and resheathing usingmechanical means, such as wire tethers.

The ability of the first housing 112 to move relative to the secondhousing 114 in a telescoping manner to deploy the device 102 results ina delivery capsule 108 that is relatively compact in length (e.g., alength of 40 mm or less) and that requires relatively short overalllongitudinal translation (e.g., 50 mm or less, 40 mm or less, etc.) todeploy the device 102. For example, the telescoping delivery capsule 108inherently requires less longitudinal translation for deployment than ifthe delivery capsule 108 were defined by a single housing that movesdistally or proximally to deploy the device 102, or two separatehousings that move in opposite directions to deploy the device 102. Thisshorter longitudinal translation in solely the distal directionfacilitates trans-septal delivery of the device 102 to a native mitralvalve of a human patient. For a typical patient with functional mitralvalve regurgitation (“FMR”), the distance across the left atrium isestimated to be about 50 mm and the length of the left ventricle isestimated to be about 70 mm. During trans-septal delivery of the device102, the delivery capsule 108 can extend through the opening in theseptal wall between the right and left atria and be positioned in orproximate to the mitral valve annulus by bending the distal portion 106a of the catheter body 106 from the left atrium into the mitral valve.The compact size of the delivery capsule 108 facilitates positioning thedelivery capsule 108 into the left atrium and making the turn into thenative mitral valve without being limited by the anatomical sizing ofthe right atrium. During device deployment, the telescoping deliverycapsule 108 does not require any portion of the delivery capsule 108 toextend in a proximal direction into the left atrium of the heart, andthe telescoping arrangement of the first and second housings 112 and 114results in a short overall longitudinal translation (relative to theaxial length of the device 102) of the housings 112, 114 into the leftventricle of the heart, much less than typical length of the leftventricle. Thus, the telescoping delivery capsule 108 avoids the typicalconstraints associated with trans-septal delivery and the associatedanatomy proximate to the target site in the mitral valve.

FIG. 7A is an enlarged side isometric view of the delivery capsule 108of the delivery system 100 of FIG. 6 configured in accordance withembodiments of the present technology, and FIG. 7B is an exploded viewof the delivery capsule 108 of FIG. 7A. The delivery capsule 108includes the first housing 112 partially overlapping and movablerelative to the second housing 114. The first and second housings 112and 114 are shown as transparent for illustrative purposes in FIGS. 7Aand 7B; however, the first and second housings 112 and 114 may be madefrom opaque materials, including metals, polymers, plastics, composites,and/or combinations thereof. In certain embodiments, the first housing112 has a length of about 20-30 mm, the second housing has a length ofabout 20-30 mm, and the first and second housings 112 and 114 overlap insuch a manner that the overall longitudinal length of the deliverycapsule 108 is 50 mm or less (e.g., 45 mm, 40 mm, etc.) when in theinitial containment or delivery state. In various embodiments, such aswhen the delivery capsule 108 is configured to retain a prostheticmitral valve device, the first housing 112 may have an outer diameter ofabout 11.58 mm and an inner diameter of about 10.82 mm, and the secondhousing 114 may have an outer diameter of about 9.53 mm and an innerdiameter of about 9.02 mm. In other embodiments, the first and secondhousings 112 and 114 have different dimensions suitable for storing anddelivering the medical device contained therein.

The delivery capsule 108 further includes a plurality of sealing members(identified individually as first through third sealing members 140 a-c,respectively; referred to collectively as “sealing members 140”), suchas sealing sleeves and/or O-rings, that can fluidically seal portions ofthe delivery capsule to define a first fluid chamber 142, a second fluidchamber 144, and/or portions thereof. The sealing members 140 can besleeves, O-rings, O-rings positioned within sleeves, and/or othersealing features that are fixedly attached to the first housing 112, thesecond housing 114, and/or other portions of the delivery capsule 108via bonding, laser welding, and/or other mechanisms for securing thesealing members 140 in position on portions of the delivery capsule 108.In certain embodiments, for example, the first and second housings 112and 114 can include sleeves or flanges formed in or on the surfaces ofthe housings 112, 114 (e.g., using 3D printing) and configured toreceive O-rings and/or other sealing features. As shown in FIGS. 7A and7B, the first sealing member 140 a can be fixedly attached to the firsthousing 112, extend between an inner surface of a distal portion 146 ofthe first housing 112 and an outer surface of the second housing 114,and be slidable relative to the second housing 114. The second sealingmember 140 b can be fixedly attached to the second housing 114 andextend between an outer surface of a proximal portion 148 of the secondhousing and the inner surface of the first housing 112. Thus, the firstfluid chamber 142 can be defined at a distal end by the first sealingmember 140 a, at a proximal end by the second sealing member 140 b, andthe portions of an inner surface of the first housing 112 and an outersurface of the second housing 114 that extend between the first andsecond sealing members 140 a and 140 b. During deployment, the firstsealing member 140 a slides distally along the outer surface of thesecond housing 114 as the first fluid chamber 142 is pressurized withfluid to move the first housing 112 in a distal direction over a portionof the second housing 114.

The second fluid chamber 144 is positioned within the second housing 114and can be defined at a proximal end by the third sealing member 140 c.As shown in FIG. 7A, for example, the delivery capsule 108 can furtherinclude a platform 150 that extends outwardly from the distal endportion of the elongated body 106 and/or other shaft extending into thedelivery capsule 108, and the third sealing member 140 c can extend fromthe platform 150 (e.g., from a surface on or a recess within theplatform 150) to the inner surface of the second housing 114 tofluidically seal the second fluid chamber 144 at a proximal end fromother portions of the delivery capsule 108. In other embodiments, theplatform 150 can itself seal against the inner surface of the secondhousing 114 to fluidically seal the proximal end of the second fluidchamber 144. As further shown in FIG. 7A, the second fluid chamber 144can be defined at its distal end by a distal end feature 152 (e.g., anose cone) at a distal end portion 154 of the second housing 114, or byanother portion of or within the second housing 114. Thus, the secondfluid chamber 144 is defined at its proximal end by a distal-facingportion of the platform 150 and/or the third sealing member 140 c, at adistal end by the distal end feature 152 or (if the end feature 152 isomitted) an interior distal end of the second housing 114, and the wallof the second housing 114 extending therebetween. During deployment, thethird sealing member 140 c, in conjunction with the platform 150, slidesalong the inner surface of the second housing 114 as the second fluidchamber 144 is pressurized with fluid to move the second housing 114,together with the first housing 112 as a unit, in a distal direction.

The platform 150 is fixed relative to the body 106 and/or another shaftextending therethrough, and can be configured to support a distal endportion of a prosthetic heart valve device (e.g., the device 102 of FIG.6) during delivery. For example, the platform 150 can be configured tomaintain the device in a substantially constant axial position relativeto the native anatomy (e.g., the mitral valve) as the first and secondhousings 112 and 114 move in a distal direction to unsheathe the device.In other embodiments, the platform 150 can be pulled or otherwise movedin a proximal direction to further unsheathe the device. The platform150 can be formed integrally with the body 106, or the body 106 and theplatform 150 can be separate components made from metal, polymers,plastic, composites, combinations thereof, and/or other suitablematerials.

The end feature 152 at the distal portion 154 of the second housing 114can be a nose cone or other element that provides stability to thedistal end of the delivery capsule 108 and/or defines an atraumatic tipto facilitate intraluminal delivery of the capsule 108. The end feature152 can be integrally formed at the distal end portion 154 of the secondhousing 114, a separate component fixedly attached thereto, or definedby the distal end of the second housing 114. As shown in FIGS. 7A and7B, the end feature 152 may include a channel 155 extending through itslength and in communication with the distal opening 134 through whichvarious components of the system 100 can extend beyond the distal endportion 154 of the delivery capsule 108. For example, the channel 155can be used to carry a guidewire (e.g., the guidewire 124 of FIG. 6), afluid lumen (discussed in further detail below), and/or a small shaftthrough which the guidewire, fluid lumen, and/or other system componentscan extend. O-rings, valves or other sealing members can be positionedin or around the channel 155 and the components extending therethroughto fluidically seal the second chamber 144 at the distal end from theexternal environment. In other embodiments, the end feature 152 caninclude multiple channels that extend to separate distal openings.

As further shown in FIG. 7A, the delivery capsule 108 also includes aseparate compartment 156 fluidically sealed from the first and secondfluid chambers 142 and 144 and configured to house a prosthetic heartvalve device (e.g., the device 102 of FIG. 6) in the unexpanded,containment state. The compartment 156 can be defined at a distal end bya proximal-facing surface of the platform 150, at a proximal end by theproximal cap 136 or the proximal end of the first housing 112, and theinterior walls of the first and second housings 112 and 114 extendingtherebetween. In embodiments where the proximal cap 136 is omitted, theproximal portion of the compartment 156 is open to the surroundingenvironment (e.g., the vasculature). In various embodiments, theplatform 150 can include engagement features that releasably couple toportions of the device to facilitate loading of the device into thedelivery capsule 108 and secure the device to the delivery capsule 108until final deployment to allow for resheathing. During deployment, thecompartment 156 is opened to the native environment at the target siteby the distal movement of the first and second housings 112 and 114relative to the platform 150, and, optionally, by proximal movement ofthe proximal cap 136.

The delivery system 100 further includes fluid lines (identifiedindividually as a first fluid line 158 a and a second fluid line 158 b;referred to collectively as “fluid lines 158”) in fluid communicationwith the first and second fluid chambers 142 and 144 via fluid ports(identified individually as a first fluid port 160 a and a second fluidport 160 b; referred to collectively as “fluid ports 160”). As shown inFIG. 7A, the first fluid line 158 a is in fluid communication with thefirst fluid chamber 142 via the first fluid port 160 a, and the secondfluid line 158 b is in fluid communication with the second fluid chamber144 via the second fluid port 160 b. The fluid ports 160 can includevalves or other features with openings that regulate fluid to flow intoand/or out of the fluid chambers 142, 144. The fluid lines 158 extendfrom the first and second fluid chambers 142 and 144 through theelongated catheter body 106, and are placed in fluid communication witha fluid source (e.g., the fluid assembly 116 of FIG. 6) at the proximalportion 106 b (FIG. 6) of the catheter body 106 such that the fluidlines 158 can deliver fluid to and, optionally, remove fluid from thefirst and second fluid chambers 142 and 144 independently of each other.In several embodiments, the first and second fluid chambers 142 and 144each have a dedicated fluid line 158 extending through or defined byportions of the catheter body 106, or a single fluid line may extendthrough the catheter body 106 and a valve assembly can be used toselectively deliver fluid to the first and second fluid chambers 142 and144.

At the distal portion 106 a of the catheter body 106, the first fluidline 158 a extends in a distal direction from the main catheter body106, through the distal end of the second housing 114 (e.g., through thechannel 155 of the end feature 152 and through the opening 134), outsidethe second housing 114, and into the first fluid port 160 a in fluidcommunication with the first fluid chamber 142. In the embodimentillustrated in FIG. 7A, the first fluid line 158 a extends through thefirst sealing member 140 a and the first fluid port 160 a is positionedon a proximal-facing surface of the first sealing member 140 a in fluidcommunication with the first fluid chamber 142. In other embodiments,the first fluid line 158 a can extend through the wall of the firsthousing 112 and/or another portion of the delivery capsule 108 tofluidly communicate with the first fluid chamber 142. The portion of thefirst fluid line 158 a that extends beyond the distal end of the maincatheter body 106 and outside of the second housing 114 can be anumbilical cord-type tube or lumen. Although FIG. 7A illustrates the tubespaced apart from the outer surface of the second housing 114, the fluidlumen can run tightly along the distal end feature 152 and the outersurface of the second housing 114. In other embodiments, the distalportion of the first fluid line 158 a can be a corrugated tube thatcoils or otherwise retracts when it is not filled with fluid, and/oranother type of tube or structure configured to transport fluid to thefirst fluid chamber 142.

As further shown in FIG. 7A, the second fluid line 158 b can terminateat the second fluid port 160 b positioned at the distal end of the maincatheter body 106 to place the second fluid port 160 b in fluidcommunication with the second fluid chamber 144. In other embodiments,the second fluid line 158 b can terminate at a distal-facing surface ofthe platform 150 in fluid communication with the second fluid chamber144, or the second fluid line 158 b may extend in a distal directionbeyond the distal end of the main catheter body 106 into the secondfluid chamber 144. In further embodiments, the distal portion of thesecond fluid line 158 b includes a tube (e.g., a corrugated tube, anumbilical cord-type lumen, etc.) that extends beyond the distal end ofthe main catheter body 106, through the distal end of the second housing114, and loops back into fluid communication with the second fluidchamber 144 via a fluid port in the wall of the second housing 112and/or another portion of the delivery capsule 108 in fluidcommunication with the second fluid chamber 144.

FIGS. 8A-8D are a series of illustrations showing the distal portion ofthe delivery system 100 of FIGS. 6-7B deploying and resheathing thedevice 102 via hydraulic actuation provided by filling and draining ofthe first and second fluid chambers 142 and 144. Although the followingdescription is specific to deployment of prosthetic heart valve devicesat a native mitral valve, the delivery capsule 108 can be used to deployprosthetic valves, implants, and/or other medical devices in otherportions of the body that may benefit from the short overalllongitudinal translation and compact sizing provided by the telescopingdelivery capsule 108. FIG. 8A illustrates the delivery capsule 108 inthe initial delivery state with the device 102 constrained within thecompartment 156 to allow for trans-luminal delivery of the device 102 tothe target site. For a trans-septal approach to the native mitral valve,a clinician accesses the mitral valve from the venous system (e.g., viathe transfemoral vein), navigates the delivery capsule 108 through theinferior vena cava into the right atrium, and passes the deliverycapsule 108 through an aperture formed in the atrial septal wall intothe left atrium. From the septal aperture, the clinician steers thedistal portion of the delivery capsule 108 from its initial orientation,directed generally transverse to the inlet of the native mitral valveinto axial alignment with the native mitral valve (e.g., a 90° turn)such that the distal portion of the delivery capsule 108 can passthrough the native mitral annulus partially into the left ventricle. Thecompact axial length of the delivery capsule 108 (e.g., less than 50 mm)facilitates this turn from the septal wall into the native mitral valvewithin the anatomical constraints of the left atrium, which typicallyhas a width of about 50 mm. Once the delivery capsule 108 is positionedat the desired site relative to the native mitral valve, the cliniciancan begin deployment of the device 102.

FIG. 8B illustrates the delivery capsule 108 during the first deploymentstage during which the first fluid line 158 a delivers fluid from thefluid assembly 116 (FIG. 6) to the first fluid chamber 142 via the firstfluid port 160 a. As fluid is added to the first fluid chamber 142, theincrease in pressure within the first fluid chamber 142 causes the firstsealing member 140 a and the first housing 112 attached thereto to slidein a distal direction along the outer surface of the second housing 114(as indicated by arrow 101). In certain embodiments, for example, thefirst sealing member 140 a can be configured to move relative to thesecond housing 114 when the pressure within the first fluid chamber 142exceeds a predetermined threshold, such as 4 atm to 8 atm. The totaltravel length of the first housing 112 in the distal direction duringthis first deployment stage can be at least 20 mm. In other embodiments,the first housing 112 may move smaller or greater distances depending onthe size of the delivery capsule 108 and/or the device 102 positionedtherein. The distal movement of the first housing 112 unsheathes a firstportion of the device 102, such as a brim or atrial portion, allowing itto expand against surrounding native tissue and/or provide visualizationfor proper seating within the native valve. When the delivery capsule108 includes a proximal cap, such as the proximal cap 136 shown in FIGS.8A and 8B (not shown in FIGS. 8C and 8D for illustrative purposes), thedistal movement of the first housing 112 separates the first housing 112from the proximal cap 136 to expose the device 102. In otherembodiments, the proximal cap 136 can be pulled in a proximal directionaway from the first housing 112 before or during the first deploymentstage.

FIG. 8C illustrates the delivery capsule 108 during the seconddeployment stage during which the second fluid line 158 b delivers fluidfrom the fluid assembly 116 (FIG. 6) to the second fluid chamber 144 viathe second fluid port 160 b. When the pressure within the second fluidchamber 144 exceeds a threshold level (e.g., 4-8 atm), the secondhousing 114 moves in a distal direction (as indicated by arrow 103)relative to the platform 150 and the associated third sealing member 140c as more fluid enters the second fluid chamber 144. Because the firstfluid chamber 142 and the second fluid chamber 144 operate independentlyof each other, the first housing 112 moves with the second housing 114as fluid fills or drains from the second fluid chamber 144. This distalmovement of the second housing 114 partially or fully unsheathes thedevice 102 from the delivery capsule 108, while maintaining the brim oratrial portion of the device 102 at substantially the same axialposition relative to the native annulus. In certain embodiments, thesecond housing 114 can translate 20-30 mm in the distal directiondepending upon the length of the device 102. In other embodiments,filling the second fluid chamber 144 pushes platform 150 in proximaldirection such that the platform 150 slides proximally along the innersurface of second housing 114 to deploy the remainder of the device 102.In this embodiment, the device 102 does not maintain its axial positionduring deployment. During the deployment procedure, the first and seconddeployment stages can be performed in separate and distinct timeintervals as illustrated in FIGS. 8B and 8C to allow for dual-stagedeployment of the device 102. In other embodiments, however, the firstand second deployment stages can be simultaneous or at least partiallyoverlapping such that the first and second fluid chambers 142 and 144receive fluid at the same time.

In various embodiments, the delivery capsule 108 can also be configuredto partially or fully resheathe the prosthetic heart valve device afterpartial deployment from the delivery capsule 108. FIG. 8D, for example,illustrates the delivery capsule 108 during a resheathing stage in whichthe delivery capsule 108 is driven back towards the delivery state byevacuating fluid from the first fluid chamber 142 via the first fluidline 158 a and applying a proximally directed force on the first housing112. For example, as shown in FIG. 8D, the first housing 112 may beoperably coupled to a biasing device 137 (e.g., a spring) housed in thehandle assembly 110 via a tether 135 and/or other coupling member thatextends through the catheter body 106. The biasing device 137 can act onthe first housing 112 (e.g., via the tether 135) to drive the firsthousing 112 in the proximal direction when fluid is removed from thefirst fluid chamber 142. In some embodiments, the biasing device 137 isomitted and the tether 135 itself can be manipulated at the handleassembly 110 (e.g., via an actuator) to retract the tether 135 in theproximal direction and draw the first housing 112 proximally. In variousembodiments, the biasing device 137 can be positioned within thecatheter body 106 (e.g., at the distal portion 106 a of the catheterbody 106) and/or associated with the delivery capsule 108 (e.g., asdescribed in further detail below with respect to FIG. 9B) such that thebiasing device 137 drives the first housing 112 proximally upon fluidremoval. With the fluid evacuated from the first fluid chamber 142, thefirst sealing member 140 a is allowed to slide in a proximal direction(as indicated by arrow 105) over the outer surface of the second housing114 and move the first housing 112 back over at least a portion of thedevice 102 to place the resheathed portion of the device 102 back intothe constrained, delivery state. For example, the first sealing member140 a can move in the proximal direction a desired distance and/or untilthe first sealing member 140 a contacts the second sealing member 140 b(e.g., about 20 mm). In some embodiments, resheathing can be initiatedby removing fluid from the second fluid chamber 144, or removing thefluid from both the first and second fluid chambers 142 and 144 to allowthe first housing 112 and/or second housing 114 to move back over thedevice 102. Similar to the first housing 112, the second housing 114 canbe operably coupled to a mechanism that drives the second housing 114 ina proximal direction when fluid is evacuated from the second chamber144, such as a tether, spring, and/or other biasing device. In someembodiments, a vacuum can be applied to the first fluid chamber 142and/or the second fluid chamber 144 after the fluid has been evacuatedfrom the chambers 142, 144 to facilitate moving the first housing 112and/or the second housing 114 in the proximal direction. Thisresheathing ability allows the clinician to reposition the prostheticheart valve device, in vivo, for redeployment within the mitral valve MVor remove the prosthetic heart valve device from the patient afterpartial deployment. Once the device 102 is fully deployed at the desiredlocation, the first and second housings 112 and 114 can be drawn in aproximal direction through the deployed device 102, and the elongatedcatheter body 106 can be pulled proximally along the access path (e.g.,through the aperture in the septal wall into the vasculature) forremoval from the patient. After removing the catheter 104 (FIG. 6), thecatheter 104 and the delivery capsule 108 can be discarded, or one orboth components can be cleaned and used to deliver additional prostheticdevices.

The telescoping delivery capsule 108 and the delivery system 100described above with respect to FIGS. 6-8D facilitate delivery via thetrans-septal delivery approach due to the capsule's compact length,which can accommodate the turn from the aperture in the atrial septalwall into the native mitral valve necessary to position the device 102in the native mitral valve without contacting the left atrial wall. Inaddition, the telescoping deployment provided by the first and secondhousings 112 and 114 results in short overall axial displacement of thedelivery capsule 108 (relative to the length of the device 102) into theleft ventricle during device deployment, and is thereby expected toavoid contact with portions of the left ventricle wall duringdeployment. By avoiding contact with the walls of the left ventricle andleft atrium, the delivery system 100 also reduces the likelihood ofarrhythmia during valve deployment. The hydraulic-actuation of thedelivery capsule 108 provides controlled movement of the first andsecond housings 112 and 114 as the device 102 expands duringunsheathing, and in certain embodiments allows the clinician toselectively suspend distal movement of the housings 112, 114 during anypoint of the deployment process to allow for repositioning and/orvisualization. Further, the delivery capsule 108 may also be configuredto at least substantially inhibit axial translation of the device 102during deployment and resheathing (e.g., as shown in FIGS. 8A-8B) tofacilitate accurate delivery to the target site.

In other embodiments, the telescoping delivery capsule 108 can operatein the opposite manner with respect to the distal portion 106 a of thecatheter body 106 such that the telescoping housings 112, 114 areconfigured to retract in a proximal direction to deploy the device 102from the delivery capsule 108 and move in a distal direction toresheathe the device 102. Such an embodiment would be suitable todeliver the device 102 to the mitral valve from the left ventricle usinga trans-apical approach (e.g., via an opening formed in the apicalportion of the left ventricle). For example, the hydraulic actuationmechanism can move the first and second housings 112 and 114 in aproximal direction in a telescoping manner toward the distal portion 106a of the catheter body 106 to unsheathe the device 102. Once the device102 is fully deployed within the mitral valve, the retracted deliverycapsule 108 (with the first housing 112 at least partially overlappingthe second housing 114) can be pulled in a proximal direction throughthe left ventricle and the apical aperture to remove the delivery system100.

FIG. 9A is a side isometric view of a distal portion of a deliverysystem 200 a configured in accordance with embodiments of the presenttechnology. The delivery system 200 a includes various features at leastgenerally similar to the features of the delivery system 100 describedabove with reference to FIGS. 6-8D. For example, the delivery system 200a includes two telescoping housings 112, 114 that are hydraulicallydriven distally and proximally between a delivery state and a deploymentstate by moving fluid to and/or from the first fluid chamber 142 and thesecond fluid chamber 144. The delivery system 200 a further includes athird or proximal fluid chamber 143 positioned in the annular spacebetween the first and second housings 112 and 114. As shown in FIG. 9A,the delivery capsule 108 includes the first sliding sealing member 140 afixedly attached to the distal portion of the first housing 112, theinternal second sealing member 140 b fixedly attached to the secondhousing 114 between the first and second housings 112 and 114, and aproximal or fourth sliding sealing member 140 d fixedly attached to theproximal portion of the first housing 112. Accordingly, the first fluidchamber 142 is between the distal-most or first sealing member 140 a andthe internal second sealing member 140 b, and the third fluid chamber143 is between the second sealing member 140 b and the proximal sealingmember 140 d. The third fluid chamber 143 can be placed in fluidcommunication with a third fluid line 158 c via a tube or otherfluid-carrying features that extend outside of the second housing 114and through the wall of the first housing 112 via a third fluid port 260c into fluid communication with the third fluid chamber 143 (e.g.,similar to the distal portion of the first fluid line 158 a). In otherembodiments, the first fluid chamber 142 and/or the third fluid chamber143 can be placed in fluid communication with the corresponding thirdfluid line 158 c using other suitable means, such as fluid channelswithin the body of the delivery capsule 108.

During device deployment, the first fluid chamber 142 is pressurizedwith fluid, thereby causing the first sealing member 140 a and the firsthousing 112 to slide distally until the proximal sealing member 140 dcomes into contact with the internal second sealing member 140 b (e.g.,about 20 mm). This unsheathes at least a portion of the device 102 fromthe delivery capsule 108. Further unsheathing can be performed bypressurizing the second fluid chamber 144 with fluid to hydraulicallymove the telescoped first and second housings 112 and 114 together inthe distal direction to partially or completely unsheathe the device102. In other embodiments, the telescoped first and second housings 112and 114 are moved together in the distal direction using mechanicalmeans. To retract the first housing 112, the first fluid chamber 142 isevacuated of fluid and the third fluid chamber 143 is pressurized withfluid via the third fluid line 158 c. This causes the proximal sealingmember 140 d and the first housing 112 to slide proximally, e.g., untilthe first sealing member 140 a stops against the internal second sealingmember 140 b. Accordingly, the supplemental third fluid chamber 143 canbe used to facilitate resheathing of the device 102 and/or retraction ofthe delivery capsule 108 back to its delivery state. In someembodiments, the delivery capsule 108 can include additional fluidchambers that further facilitate device deployment and recapture, and/orthe fluid chambers can be defined by different portions of the deliverycapsule 108, while still being configured to hydraulically drive thefirst and second housings 112 and 114 distally and/or proximallyrelative to each other.

FIG. 9B is a side isometric view of a distal portion of a deliverysystem 200 b in a delivery state configured in accordance with someembodiments of the present technology. The delivery system 200 bincludes various features at least generally similar to the features ofthe delivery system 100 described above with reference to FIGS. 6-8D.For example, the delivery system 200 b includes two telescoping housings112, 114 that are hydraulically driven distally and proximally between adelivery state and a deployment state by moving fluid to and from thefirst fluid chamber 142 and the second fluid chamber 144. The deliverysystem 200 b further includes at least one biasing device (identifiedindividually as a first biasing device 262 a and a second biasing device262 b; referred to collectively as “biasing devices 262”) that urges thefirst housing 112 and/or the second housing 114 toward the deliverystate in the absence of fluid within the first and second fluid chambers142 and 144. The biasing devices 262 can be springs (e.g., as shown inFIG. 9B) or other components that apply force on the housings 112, 114when compressed or extended during device deployment.

As illustrated in FIG. 9B, the first biasing device 262 a extends arounda portion of the second housing 114 and acts on the distal end portion146 of the first housing 112 when the first housing 112 moves toward thedeployment state. An end stop component 263 or other feature can securethe distal end of the first biasing device 262 a in place on the secondhousing 114. The first biasing device 262 a compresses as the firsthousing 112 moves in the distal direction toward the deployment state,thereby applying a force on the first housing 112 in the proximaldirection. In certain embodiments, the first biasing device 262 aapplies a constant proximally-directed force on the first housing 112when the delivery capsule 108 is in the delivery state, and that forceincreases as the first housing 112 moves in the distal direction. Inother embodiments, the first biasing device 262 a is in a neutral statewhen the delivery capsule 108 is in the delivery state, and then appliesa proximally-directed force to the first housing 112 as the firstbiasing device 262 a compresses. This proximally-directed force may notbe great enough to urge the first housing 112 closed when fluid is inthe first fluid chamber 142, but after fluid removal from the firstfluid chamber 142, the first biasing device 262 a can push the firsthousing 112 in a proximal direction to resheathe a prosthetic device(e.g., the device 102 of FIGS. 6 and 8A-8D) positioned within thedelivery capsule 108 and/or close the delivery capsule 108 for removalfrom the patient's body.

As further shown in FIG. 9B, the second biasing device 262 b ispositioned within the second housing 114 (e.g., within the second fluidchamber 144) such that it acts on the second housing 114 when the secondhousing 114 moves toward the deployment state. The second biasing device262 b can be coupled to the platform 150 at a proximal end of the secondbiasing device 262 b, and to a distal portion of the second housing 114or components therein (e.g., the distal end feature 152) at a distal endof the second biasing device 262 b. When the second fluid chamber 144fills with fluid and drives the distal end of the second housing 114apart from the platform 150, the second biasing device 262 b expands,thereby applying force on the first housing 112 and the platform 150 topull the two components closer together. In certain embodiments, thesecond biasing device 262 b applies a continual proximally-directedforce on the second housing 114 when the delivery capsule 108 is in thedelivery state, and that force increases as the second housing 114 movesin the distal direction. In other embodiments, the second biasing device262 b is in a neutral state when the delivery capsule 108 is in thedelivery state, and then applies a proximally-directed force to thesecond housing 114 as the second biasing device 262 b expands. Whenfluid is in the second fluid chamber 144, the biasing force is not of amagnitude to urge the second housing 114 toward the delivery state.However, after draining fluid from the second fluid chamber 144, thesecond biasing device 262 b can pull the second housing 114 in aproximal direction and/or pull the second housing 114 and the platform150 closer together (depending on the force required to slide theplatform 150 relative to the second housing 114) to resheathe a deviceand/or close the delivery capsule 108.

The biasing devices 262 can also limit or substantially prevent distalmovement of the housings 112, 114 attributable to the forces produced byan expanding prosthetic heart valve device (e.g., the device 102 ofFIGS. 8A-8D). For example, hydraulic actuation can move the firsthousing 112 and/or the second housing 114 to unsheathe a portion of aprosthetic heart valve device, allowing the device to expand outwardly.Meanwhile, the biasing devices 262 can urge the housings 112, 114 towardthe delivery state to counteract the distally-directed expansion forcesof the device on the delivery capsule 108, and thereby prevent axialjumping. One, two, or more biasing devices 262 can be incorporated inany of the delivery capsules disclosed herein to urge the telescopinghousings toward the deployment state. In some embodiments, the biasingdevices 262 can be positioned elsewhere with respect to the deliverycapsule 108 and/or the delivery system 200 b and operably coupled to thefirst housing 112 and/or the second housing 114 to bias the housings112, 114 toward the delivery configuration. For example, the secondbiasing device 262 b can be positioned in a proximal portion of thedelivery capsule 108 and operably coupled to the second housing 114 viaa tether or other connector such that the second biasing device 262 bacts on the second housing 114. As another example, the first biasingdevice 262 a and/or the second biasing device 262 b can be positioned inportions of the catheter body 106 and/or a handle assembly (the handleassembly 110 of FIG. 6), and connected to the first and second housings112 and 114 via tethers or other connectors extending through thecatheter body 106.

FIGS. 10A and 10B are a partial cut-away isometric view and across-sectional view, respectively, of a distal portion of a deliverysystem 300 configured in accordance with some embodiments of the presenttechnology. The delivery system 300 includes various features at leastgenerally similar to the features of the delivery systems 100, 200 a,200 b described above with reference to FIGS. 6-9. For example, thedelivery system 300 includes a telescoping delivery capsule 308 having afirst housing 312, a second housing 314 slidably disposed within aportion of the first housing 312, and two fluid chambers (identifiedindividually as a first fluid chamber 342 and a second fluid chamber344) defined at least in part by sealing members 340 (identifiedindividually as first through third sealing members 340 a-c,respectively). More specifically, the first fluid chamber 342 is definedby the annular space between the first and second sealing members 340 aand 340 b, and the second fluid chamber 344 is defined by the portion ofthe second housing 314 between a platform 350 (including the thirdsealing member 340 c) and a distal end portion 352. The first and secondfluid chambers 342 and 344 are placed in fluid communication with afluid source (e.g., the fluid assembly 116 of FIG. 6) via dedicatedfluid lines 358 (identified individually as a first fluid line 358 a anda second fluid line 358 b).

In the embodiment illustrated in FIGS. 10A and 10B, the second fluidline 158 b is a tube or shaft that extends through an elongated catheterbody (not shown; e.g., the catheter body 106 of FIGS. 6-9) and affixesto the platform 350 where it terminates at a second fluid port 360 b todeliver fluid to and/or remove fluid from the second fluid chamber 344(as indicated by arrows 309). The first fluid line 358 a includes a tubeor channel that extends through the length of the second fluid line 358b, projects in a distal direction beyond the second port 358 b and theplatform 350, and then extends distally into the second fluid chamber344 where the first fluid line 358 a connects to one or more lumens 370defined by the annular space in the wall of the second housing 114. Thelumen 370 extends through the wall of the second housing 314 to thefirst fluid port 360 a, which allows fluid to be delivered to and/orremoved from the first fluid chamber 342 (as indicated by arrows 307).The portion of the first fluid line 358 a that extends between thesecond fluid line 358 b and the lumen 370 can be a flexible tube orcorrugated lumen bonded to or otherwise sealed to the inlet of the lumen370. Such flexible tubes or corrugated lumens allow the first fluid line358 b to bend, flex, and extend to maintain the connection with thelumen 370 as the platform 350 and the second housing 314 move relativeto each other when the second fluid chamber 344 is filled or drained. Inother embodiments, the first fluid line 358 a and the second fluid line358 b run alongside each other, rather than concentrically, within anelongated catheter body or defined by separate portions of the catheterbody.

In operation, fluid is delivered to the first fluid chamber 342 via thefirst fluid line 358 a, which causes the first housing 312 to move in adistal direction over the second housing 314 to unsheathe a portion of aprosthetic heart valve device (e.g., the device 102 of FIGS. 7A-8D). Ina subsequent or simultaneous step, fluid is delivered to the secondfluid chamber 344 via the second fluid line 358 b, causing the secondhousing 314 to move in the distal direction to further unsheathe theprosthetic heart valve device. During an optional resheathing stage,fluid can be removed from the first fluid chamber 342 via the firstfluid line 358 a and, optionally, the first fluid chamber 342 can bepressurized to move the first housing 312 in a proximal direction backover the prosthetic heart valve device. Further resheathing can beperformed by draining and, optionally, applying a vacuum to the secondfluid chamber 344.

FIGS. 10C and 10D are cutaway isometric views of housing configurationsfor use with the delivery system 300 of FIGS. 10A and 10B. Morespecifically, FIGS. 10C and 10D illustrate different configurations of asecond housing 414, 514 having lumens within the housing wall such thatthe second housing 414, 514 can define an end portion of a first fluidline (e.g., the first fluid line 358 a of FIGS. 10A and 10B) in fluidcommunication with a first fluid chamber (e.g., the first fluid chamber342 of FIGS. 10A and 10B). In some embodiments as illustrated in FIG.10C, the second housing 414 includes four oblong or oval-shaped lumens(identified individually as first through fourth lumens 470 a-b,respectively; referred to collectively as lumens 470) spaced equallyabout the circumference of the second housing 414 and extending throughat least a portion of the wall of the second housing 414. In someembodiments as illustrated in FIG. 10D, the second housing 514 includesfour circular lumens (identified individually as first through fourthlumens 570 a-b, respectively; referred to collectively as lumens 570)spaced equally about the circumference of the second housing 514 andextending through at least a portion of the wall of the second housing514. In some embodiments, each lumen 470, 570 has a first end coupled toa portion of the first fluid line (e.g., the first fluid line 358 a ofFIGS. 10A and 10B) extending from a proximal portion of a catheter body(e.g., the catheter bodies 106, 306 of FIGS. 6, 10A and 10B) via aflexible tube or other feature, and a second end that is placed in fluidcommunication with a first fluid chamber (e.g., the first fluid chamber342 of FIGS. 10A and 10B) via individual fluid ports. In someembodiments, only one of the lumens 470, 570 is coupled to a portion ofthe first fluid line (e.g., the first fluid line 358 a of FIGS. 10A and10B) extending from a proximal portion of a catheter body (e.g., thecatheter bodies 106, 306 of FIGS. 6, 10A and 10B) via a flexible tube orother feature, and the second housing 414, 514 includes additionalinternal lumens that connect the other lumens 470, 570 to each othersuch that the lumens 470, 570 can be placed in fluid communication witha first fluid chamber (e.g., the first fluid chamber 342 of FIGS. 10Aand 10B) via individual fluid ports. In some embodiments, the secondhousing 414, 514 includes one, two, three, or more than four lumens 470,570 spaced equidistance or at other desired locations around thecircumference of the second housing 414, 514. In still furtherembodiments, the lumens 470, 570 may have different cross-sectionalshapes suitable for carrying fluid. Any of the configurations of thesecond housings 314, 414, 514 described with reference to FIGS. 10A-10Dcan also replace the second housing 114 in the delivery systems 100, 200a, 200 b described above with reference to FIGS. 6-9.

FIGS. 11A and 11B are isometric and cross-sectional views of a distalportion of a delivery system 600 configured in accordance with someembodiments of the present technology. The delivery system 600 includesvarious features at least generally similar to the features of thedelivery systems 100, 200 a, 200 b, 300 described above with referenceto FIGS. 6-10D. For example, the delivery system 600 includes anelongated catheter body 606 and a telescoping delivery capsule 608 at adistal end portion 606 a of the catheter body 606. The delivery capsule608 includes a first housing 612 and a second housing 614 slidablydisposed within a portion of the first housing 612 such that, duringdeployment, the first housing 612 moves in a distal direction over thesecond housing 614 to release at least a portion of a prosthetic heartvalve device (e.g., the device 102 of FIGS. 6 and 8A-8D) from thedelivery capsule 608.

Rather than the hydraulically-actuated first and second housingsdescribed with reference to FIGS. 6-10D, the delivery capsule 608 ofFIGS. 11A and 11B moves the first and second housings 612 and 614 usingnon-fluidic means. For example, the delivery system 600 includes aplurality of tether elements (identified individually as a first tetherelement 664 a and a second tether element 664 b; referred tocollectively as “tether elements 664”) coupled to a distal portionand/or other portion of the first housing 612 at correspondingattachment features 666 and configured to move the first housing 612relative to the second housing 614. The tether elements 664 can be canbe wires, sutures, cables, and/or other suitable structures for drivingmovement of the first housing 612, and the attachment features 666 caninclude adhesives, interlocking components, hooks, eyelets, and/or othersuitable fasteners for joining one end portion of the tether elements664 to the first housing 612. Although two tether elements 664 are shownin FIGS. 11A and 11B, the delivery system 600 can include a singletether element and/or more than two tether elements to drive movement ofthe first housing 612.

The tether elements 664 extend from the first housing 612 in a distaldirection over a distal end portion 654 of the second housing 614 (e.g.,a nose cone), into a distal opening 634 of the second housing 614, andin a proximal direction through the catheter body 606. At a proximalportion of the delivery system 600, proximal end portions of the tetherelements 664 can be attached to actuators of a handle assembly (e.g.,the handle assembly 110 of FIG. 6) and/or otherwise accessible to allowa clinician to pull or otherwise proximally retract the tether elements664 (as indicated by the arrows associated with the proximal ends of thetether elements 664). During this proximal retraction of the tetherelements 664, the distal end portion 654 of the second housing 614serves as a pulley to change the direction of motion, and thereby movethe first housing 612 in a distal direction (as indicated by arrows 611of FIG. 11B). This causes the first housing 612 to slide over the secondhousing 614 such that at least a portion of the second housing 614 istelescoped within the first housing 612 and the prosthetic heart valvedevice is unsheathed from the first housing 612.

The remainder of the prosthetic heart valve device can be unsheathedfrom the delivery capsule 608 in a subsequent deployment step by movingthe second housing 614 (together with the first housing 612) in a distaldirection. For example, the second housing 614 can be driven in thedistal direction using mechanical means (e.g., rods or pistons) to pushthe second housing 614 distally, or the second housing 614 can move viahydraulic means by moving fluid to one or more fluid chambers (e.g.,similar to the fluid chambers described above with reference to FIGS.6-10D). In other embodiments, a piston device and/or other feature canbe used to push the prosthetic heart valve device in a proximaldirection out from the second housing 614. Similar to the telescopingdelivery capsules described above, the mechanically-activated deliverycapsule 608 can have a compact size and a relatively short overalllongitudinal translation to deploy the prosthetic heart valve device tofacilitate trans-septal delivery of the prosthetic heart valve device tothe mitral valve. In other embodiments, the delivery capsule 608 can beused to facilitate the delivery of other types of devices to regions ofthe body that benefit from the short axial deployment paths provided bythe telescoping housings 612, 614.

In various embodiments, the delivery capsule 608 can further beconfigured to allow for resheathing a partially deployed device and/orotherwise moving the delivery capsule 608 back toward its initialdelivery state. A clinician pushes or otherwise moves the tetherelements 664 in the distal direction (e.g., via an actuator on aproximally-positioned handle assembly), thereby moving the first housing612 in a proximal direction. To accommodate such distal movement of thetether elements 664, each tether element 664 can be routed through anindividual tube or channel that extends through the catheter body 606and allows the clinician to both pull and push the tether elements 664,while inhibiting the tether elements 664 from buckling along the lengthof the catheter body 606 during proximal movement. In other embodiments,the tether elements 664 and/or portions thereof can be made fromsemi-rigid and/or rigid materials that avoid buckling when the tetherelements 664 are not placed in tension.

FIGS. 12A and 12B are isometric and cross-sectional views, respectively,of a distal portion of a delivery system 700 configured in accordancewith some embodiments of the present technology. The delivery system 700includes various features at least generally similar to the features ofthe mechanically-driven delivery system 600 described above withreference to FIGS. 11A and 11B. For example, the delivery system 700includes an elongated catheter body 706, a delivery capsule 708 withtelescoping first and second housings 712 and 714 at a distal endportion 706 a of the catheter body 706, and a plurality of tetherelements (identified individually as a first through fourth tetherelement 764 a-764 d, respectively; referred to collectively as “tetherelements 764”) coupled to portions of the first housing 712. The tetherelements 764 mechanically drive the first housing 712 in both a distaldirection to move the delivery capsule 708 toward an unsheathing ordeployment state and a proximal direction to move the delivery capsule708 back toward its initial delivery state (e.g., for resheathing thedevice). As described in further detail below, the delivery system 700includes four tether elements 764—two dedicated unsheathing tetherelements 764 that move the first housing 712 in the distal direction andtwo dedicated resheathing tether elements 764 that move the firsthousing 712 in the proximal direction. In other embodiments, however,the delivery system 700 can include a single tether element 764 or morethan two tether elements 764 to initiate distal movement of the firsthousing 712. In further embodiments, the delivery system 700 can includea single tether element or more than two tether elements 764 to initiateproximal movement of the first housing 712.

The first and second tether elements 764 a and 764 b are configured todrive the first housing 712 in the distal direction to at leastpartially unsheathe a proximal heart valve device and/or other devicestored within the delivery capsule 708. Similar to the tether elements664 of FIGS. 11A and 11B, distal end portions of the first and secondtether elements 764 a and 764 b are coupled to the first housing 712 attwo corresponding attachment features 766, from which the first andsecond tether elements 764 a and 764 b extend in a distal direction overa distal end portion 754 of the second housing 714 (e.g., a nose cone),into a distal opening 734 of the second housing 714, and then in aproximal direction through the catheter body 706. At a proximal portionof the delivery system 700, a clinician can pull or otherwise proximallyretract the first and second tether elements 764 a and 764 b (e.g., viaactuators on the handle assembly 110 of FIG. 6) to move the firsthousing 712 in a distal direction over the second housing 714 andunsheathe at least a portion of the device from the first housing 712.The remainder of the device can be unsheathed from the delivery capsule708 in a separate deployment step by moving the second housing 714(together with the first housing 712) in a distal direction viamechanical or hydraulic actuation means and/or urging the device in aproximal direction out from the second housing 714 (e.g., via a pistondevice).

The third and fourth tether elements 764 c and 764 d are used tomechanically drive the first housing 712 in the proximal direction to atleast partially resheathe the device and/or close the delivery capsule708 for removal from the patient. Distal end portions of the third andfourth tether elements 764 c and 764 d are coupled to a distal endportion of the first housing 712 at two corresponding attachmentfeatures 770, such as adhesives, interlocking components, hooks,eyelets, and/or other suitable fasteners for joining one end portion ofthe tether elements 764 to the first housing 712. As shown in FIGS. 12Aand 12B, the third and fourth tether elements 764 c and 764 d extendfrom the attachment features 770 in a proximal direction between thefirst and second housings 712 and 714 until they are routed around anarched feature (identified individually as a first arched feature 768 aand a second arched feature 768 b; referred to collectively as “archedfeatures 768”) of the second housing 714. The arched features 768 can beprotrusions or channels projecting from the outer surface of the secondhousing 714 and/or in the wall of the second housing 714, and have aU-shaped or V-shaped surface that reverses the direction of the thirdand fourth tether elements 764 c and 764 d. In the illustratedembodiment, the second housing 714 includes two arched features 768corresponding to the two tether elements 764 c-d, but in otherembodiments the second housing 714 can include a single arched feature768 and/or more than two arched features 768 that are configured toreverse the direction of one or more tether elements 764. Afterreversing direction via the arched features 768, the third and fourthtether elements 764 c and 764 d extend in a distal direction over thedistal end portion 754 of the second housing 714, into the distalopening 734, and then in a proximal direction through the catheter body706. At the proximal portion of the delivery system 700, proximal endportions of the third and fourth tether elements 764 c and 764 d can beattached to actuators of a handle assembly (e.g., the handle assembly110 of FIG. 6) and/or otherwise accessible to allow the clinician topull or otherwise proximally retract the third and fourth tetherelements 764 c and 764 d, which in turn moves the first housing 712 inthe proximal direction. In this embodiment, the arched features 768 ofthe second housing 714 serve as pulleys to change the direction ofmotion of the third and fourth tether elements 764 c and 764 d, therebymoving the first housing 712 in the proximal direction when the thirdand fourth tether elements 764 c and 764 c are proximally retracted.

In operation, the clinician can at least partially unsheathe the deviceby proximally retracting the first and second tether elements 764 a and764 b to move the first housing 712 in the distal direction toward theunsheathing state. The clinician can further unsheathe the device bymoving the second housing 714 in the distal direction. If resheathing isdesired to adjust position or remove the device from the patient, theclinician can proximally retract the third and fourth tether elements764 c and 764 d to move the first housing 712 back over the device inthe proximal direction to resheathe a portion of the device within thefirst housing 712. After full deployment of the device at the targetsite, proximal retraction of the third and fourth tether elements 764 cand 764 d can again be used to move the first housing 712 proximallysuch that the delivery capsule 708 is placed back into the deliverystate for removal from the patient. Accordingly, the delivery system 700uses proximal retraction of the tether elements 764 to mechanicallydrive the first housing 712 in both the distal and proximal directions.Similar to the telescoping delivery capsules described above, thedelivery capsule 708 of FIGS. 12A and 12B provides deployment proceduresthat require only short overall longitudinal translation relative to thedevice size to facilitate trans-septal delivery of a prosthetic heartvalve device to the mitral valve and/or deployment of medical devices toother target sites having constrained anatomical dimensions.

Selected Embodiments of Prosthetic Heart Valve Devices

The telescoping delivery systems 100, 200 a, 200 b, 300, 600 and 700described above with reference to FIGS. 6-12B can be configured todeliver various prosthetic heart valve devices, such as prosthetic valvedevices for replacement of the mitral valve and/or other valves (e.g., abicuspid or tricuspid valve) in the heart of the patient. Examples ofthese prosthetic heart valve devices, system components, and associatedmethods are described in this section with reference to FIGS. 13A-26.Specific elements, substructures, advantages, uses, and/or otherfeatures of the embodiments described with reference to FIGS. 13A-26 canbe suitably interchanged, substituted or otherwise configured with oneanother. Furthermore, suitable elements of the embodiments describedwith reference to FIGS. 13A-26 can be used as stand-alone and/orself-contained devices.

FIG. 13A is a side cross-sectional view and FIG. 13B is a top plan viewof a prosthetic heart valve device (“device”) 1100 in accordance with anembodiment of the present technology. The device 1100 includes a valvesupport 1110, an anchoring member 1120 attached to the valve support1110, and a prosthetic valve assembly 1150 within the valve support1110. Referring to FIG. 13A, the valve support 1110 has an inflow region1112 and an outflow region 1114. The prosthetic valve assembly 1150 isarranged within the valve support 1110 to allow blood to flow from theinflow region 1112 through the outflow region 1114 (arrows BF), butprevent blood from flowing in a direction from the outflow region 1114through the inflow region 1112.

In the embodiment shown in FIG. 13A, the anchoring member 1120 includesa base 1122 attached to the outflow region 1114 of the valve support1110 and a plurality of arms 1124 projecting laterally outward from thebase 1122. The anchoring member 1120 also includes a fixation structure1130 extending from the arms 1124. The fixation structure 1130 caninclude a first portion 1132 and a second portion 1134. The firstportion 1132 of the fixation structure 1130, for example, can be anupstream region of the fixation structure 1130 that, in a deployedconfiguration as shown in FIG. 13A, is spaced laterally outward apartfrom the inflow region 1112 of the valve support 1110 by a gap G. Thesecond portion 1134 of the fixation structure 1130 can be adownstream-most portion of the fixation structure 1130. The fixationstructure 1130 can be a cylindrical ring (e.g., straight cylinder orconical), and the outer surface of the fixation structure 1130 candefine an annular engagement surface configured to press outwardlyagainst a native annulus of a heart valve (e.g., a mitral valve). Thefixation structure 1130 can further include a plurality of fixationelements 1136 that project radially outward and are inclined toward anupstream direction. The fixation elements 1136, for example, can bebarbs, hooks, or other elements that are inclined only in the upstreamdirection (e.g., a direction extending away from the downstream portionof the device 1100).

Referring still to FIG. 13A, the anchoring member 1120 has a smooth bend1140 between the arms 1124 and the fixation structure 1130. For example,the second portion 1134 of the fixation structure 1130 extends from thearms 1124 at the smooth bend 1140. The arms 1124 and the fixationstructure 1130 can be formed integrally from a continuous strut orsupport element such that the smooth bend 1140 is a bent portion of thecontinuous strut. In other embodiments, the smooth bend 1140 can be aseparate component with respect to either the arms 1124 or the fixationstructure 1130. For example, the smooth bend 1140 can be attached to thearms 1124 and/or the fixation structure 1130 using a weld, adhesive orother technique that forms a smooth connection. The smooth bend 1140 isconfigured such that the device 1100 can be recaptured in a capsule orother container after the device 1100 has been at least partiallydeployed.

The device 1100 can further include a first sealing member 1162 on thevalve support 1110 and a second sealing member 1164 on the anchoringmember 1120. The first and second sealing members 1162, 1164 can be madefrom a flexible material, such as Dacron® or another type of polymericmaterial. The first sealing member 1162 can cover the interior and/orexterior surfaces of the valve support 1110. In the embodimentillustrated in FIG. 13A, the first sealing member 1162 is attached tothe interior surface of the valve support 1110, and the prosthetic valveassembly 1150 is attached to the first sealing member 1162 andcommissure portions of the valve support 1110. The second sealing member1164 is attached to the inner surface of the anchoring member 1120. As aresult, the outer annular engagement surface of the fixation structure1130 is not covered by the second sealing member 1164 so that the outerannular engagement surface of the fixation structure 1130 directlycontacts the tissue of the native annulus.

The device 1100 can further include an extension member 1170. Theextension member 1170 can be an extension of the second sealing member1164, or it can be a separate component attached to the second sealingmember 1164 and/or the first portion 1132 of the fixation structure1130. The extension member 1170 can be a flexible member that, in adeployed state (FIG. 13A), flexes relative to the first portion 1132 ofthe fixation structure 1130. In operation, the extension member 1170guides the device 1100 during implantation such that the device 1100 islocated at a desired elevation and centered relative to the nativeannulus. As described below, the extension member 1170 can include asupport member, such as a metal wire or other structure, that can bevisualized via fluoroscopy or other imaging techniques duringimplantation. For example, the support member can be a radiopaque wire.

FIGS. 14A and 14B are cross-sectional views illustrating an example ofthe operation of the smooth bend 1140 between the arms 1124 and thefixation structure 1130 in the recapturing of the device 1100 afterpartial deployment. FIG. 14A schematically shows the device 1100 loadedinto a capsule 1700 of a delivery system in a delivery state, and FIG.14B schematically shows the device 1100 in a partially deployed state.Referring to FIG. 14A, the capsule 1700 has a housing 1702, a pedestalor support 1704, and a top 1706. In the delivery state shown in FIG.14A, the device 1100 is in a low-profile configuration suitable fordelivery through a catheter or cannula to a target implant site at anative heart valve.

Referring to FIG. 14B, the housing 1702 of the capsule 1700 has beenmoved distally such that the extension member 1170, fixation structure1130 and a portion of the arms 1124 have been released from the housing1702 in a partially deployed state. This is useful for locating thefixation structure 1130 at the proper elevation relative to the nativevalve annulus A such that the fixation structure 1130 expands radiallyoutward into contact the inner surface of the native annulus A. However,the device 1100 may need to be repositioned and/or removed from thepatient after being partially deployed. To do this, the housing 1702 isretracted (arrow R) back toward the fixation structure 1130. As thehousing 1702 slides along the arms 1124, the smooth bend 1140 betweenthe arms 1124 and the fixation structure 1130 allows the edge 1708 ofthe housing 1702 to slide over the smooth bend 1140 and therebyrecapture the fixation structure 1130 and the extension member 1170within the housing 1702. The device 1100 can then be removed from thepatient or repositioned for redeployment at a better location relativeto the native annulus A. Further aspects of prosthetic heart valvedevices in accordance with the present technology and their interactionwith corresponding delivery devices are described below with referenceto FIGS. 15-26.

FIG. 15 is a top isometric view of an example of the device 1100. Inthis embodiment, the valve support 1110 defines a first frame (e.g., aninner frame) and fixation structure 1130 of the anchoring member 1120defines a second frame (e.g., an outer frame) that each include aplurality of structural elements. The fixation structure 1130, morespecifically, includes structural elements 1137 arranged indiamond-shaped cells 1138 that together form at least a substantiallycylindrical ring when freely and fully expanded as shown in FIG. 15. Thestructural elements 1137 can be struts or other structural featuresformed from metal, polymers, or other suitable materials that canself-expand or be expanded by a balloon or other type of mechanicalexpander.

In several embodiments, the fixation structure 1130 can be a generallycylindrical fixation ring having an outwardly facing engagement surface.For example, in the embodiment shown in FIG. 15, the outer surfaces ofthe structural elements 1137 define an annular engagement surfaceconfigured to press outwardly against the native annulus in the deployedstate. In a fully expanded state without any restrictions, the walls ofthe fixation structure 1130 are at least substantially parallel to thoseof the valve support 1110. However, the fixation structure 1130 can flexinwardly (arrow I) in the deployed state when it presses radiallyoutwardly against the inner surface of the native annulus of a heartvalve.

The embodiment of the device 1100 shown in FIG. 15 includes the firstsealing member 1162 lining the interior surface of the valve support1110, and the second sealing member 1164 along the inner surface of thefixation structure 1130. The extension member 1170 has a flexible web1172 (e.g., a fabric) and a support member 1174 (e.g., metal orpolymeric strands) attached to the flexible web 1172. The flexible web1172 can extend from the second sealing member 1164 without ametal-to-metal connection between the fixation structure 1130 and thesupport member 1174. For example, the extension member 1170 can be acontinuation of the material of the second sealing member 1164. Severalembodiments of the extension member 1170 are thus a malleable or floppystructure that can readily flex with respect to the fixation structure1130. The support member 1174 can have a variety of configurations andbe made from a variety of materials, such as a double-serpentinestructure made from Nitinol.

FIG. 16 is a side view and FIG. 17 is a bottom isometric view of thedevice 1100 shown in FIG. 15. Referring to FIG. 16, the arms 1124 extendradially outward from the base portion 1122 at an angle α selected toposition the fixation structure 1130 radially outward from the valvesupport 1110 (FIG. 15) by a desired distance in a deployed state. Theangle α is also selected to allow the edge 1708 of the delivery systemhousing 1702 (FIG. 14B) to slide from the base portion 1122 toward thefixation structure 1130 during recapture. In many embodiments, the angleα is 15°-75°, or more specifically 15°-60°, or still more specifically30°-45°. The arms 1124 and the structural elements 1137 of the fixationstructure 1130 can be formed from the same struts (i.e., formedintegrally with each other) such that the smooth bend 1140 is acontinuous, smooth transition from the arms 1124 to the structuralelements 1137. This is expected to enable the edge 1708 of the housing1702 to more readily slide over the smooth bend 1140 in a manner thatallows the fixation structure 1130 to be recaptured in the housing 1702of the capsule 1700 (FIG. 14B). Additionally, by integrally forming thearms 1124 and the structural elements 1137 with each other, it inhibitsdamage to the device 1100 at a junction between the arms 1124 and thestructural elements 1137 compared to a configuration in which the arms1124 and structural elements 1137 are separate components and welded orotherwise fastened to each other.

Referring to FIGS. 16 and 17, the arms 1124 are also separated from eachother along their entire length from where they are connected to thebase portion 1122 through the smooth bend 1140 (FIG. 16) to thestructural elements 1137 of the fixation structure 1130. The individualarms 1124 are thus able to readily flex as the edge 1708 of the housing1702 (FIG. 14B) slides along the arms 1124 during recapture. This isexpected to reduce the likelihood that the edge 1708 of the housing 1702will catch on the arms 1124 and prevent the device 1100 from beingrecaptured in the housing 1702.

In one embodiment, the arms 1124 have a first length from the base 1122to the smooth bend 1140, and the structural elements 1137 of thefixation structure 1130 at each side of a cell 1138 (FIG. 15) have asecond length that is less than the first length of the arms 1124. Thefixation structure 1130 is accordingly less flexible than the arms 1124.As a result, the fixation structure 1130 is able to press outwardlyagainst the native annulus with sufficient force to secure the device1100 to the native annulus, while the arms 1124 are sufficientlyflexible to fold inwardly when the device is recaptured in a deliverydevice.

In the embodiment illustrated in FIGS. 15-17, the arms 1124 and thestructural elements 1137 are configured such that each arm 1124 and thetwo structural elements 1137 extending from each arm 1124 formed aY-shaped portion 1142 (FIG. 17) of the anchoring member 1120.Additionally, the right-hand structural element 1137 of each Y-shapedportion 1142 is coupled directly to a left-hand structural element 1137of an immediately adjacent Y-shaped portion 1142. The Y-shaped portions1142 and the smooth bends 1140 are expected to further enhance theability to slide the housing 1702 along the arms 1124 and the fixationstructure 1130 during recapture.

FIG. 18 is a side view and FIG. 19 is a bottom isometric view of aprosthetic heart valve device (“device”) 1200 in accordance with anotherembodiment of the present technology. The device 1200 is shown withoutthe extension member 1170 (FIGS. 15-17), but the device 1200 can furtherinclude the extension member 1170 described above. The device 1200further includes extended connectors 1210 projecting from the base 1122of the anchoring member 1120. Alternatively, the extended connectors1210 can extend from the valve support 1110 (FIGS. 13A-17) in additionto or in lieu of extending from the base 1122 of the anchoring member1120. The extended connectors 1210 can include a first strut 1212 aattached to one portion of the base 1122 and a second strut 1212 battached to another portion of the base 1122. The first and secondstruts 1212 a-b are configured to form a V-shaped structure in whichthey extend toward each other in a downstream direction and areconnected to each other at the bottom of the V-shaped structure. TheV-shaped structure of the first and second struts 1212 a-b causes theextension connector 1210 to elongate when the device 1200 is in alow-profile configuration within the capsule 1700 (FIG. 14A) duringdelivery or partial deployment. When the device 1200 is fully releasedfrom the capsule 1700 (FIG. 14A) the extension connectors 1210foreshorten to avoid interfering with blood flow along the leftventricular outflow tract.

The extended connectors 1210 further include an attachment element 1214configured to releasably engage a delivery device. The attachmentelement 1214 can be a T-bar or other element that prevents the device1200 from being released from the capsule 1700 (FIG. 14A) of a deliverydevice until desired. For example, a T-bar type attachment element 1214can prevent the device 1200 from moving axially during deployment orpartial deployment until the housing 1702 (FIG. 14A) moves beyond theportion of the delivery device engaged with the attachment elements1214. This causes the attachment elements 1214 to disengage from thecapsule 1700 (FIG. 14A) as the outflow region of the valve support 1110and the base 1122 of the anchoring member 1120 fully expand to allow forfull deployment of the device 1200.

FIG. 20 is a side view and FIG. 21 is a bottom isometric view of thedevice 1200 in a partially deployed state in which the device 1200 isstill capable of being recaptured in the housing 1702 of the deliverydevice 1700. Referring to FIG. 20, the device 1200 is partially deployedwith the fixation structure 1130 substantially expanded but theattachment elements 1214 (FIG. 18) still retained within the capsule1700. This is useful for determining the accuracy of the position of thedevice 1200 during implantation while retaining the ability to recapturethe device 1200 in case it needs to be repositioned or removed from thepatient. In this state of partial deployment, the elongated first andsecond struts 1212 a-b of the extended connectors 1210 space the base1122 of the anchoring member 1120 and the outflow region of the valvesupport 1110 (FIG. 13A) apart from the edge 1708 of the capsule 1700 bya gap G.

Referring to FIG. 21, the gap G enables blood to flow through theprosthetic valve assembly 1150 while the device 1200 is only partiallydeployed. As a result, the device 1200 can be partially deployed todetermine (a) whether the device 1200 is positioned correctly withrespect to the native heart valve anatomy and (b) whether proper bloodflow passes through the prosthetic valve assembly 1150 while the device1200 is still retained by the delivery system 1700. As such, the device1200 can be recaptured if it is not in the desired location and/or ifthe prosthetic valve is not functioning properly. This additionalfunctionality is expected to significantly enhance the ability toproperly position the device 1200 and assess, in vivo, whether thedevice 1200 will operate as intended, while retaining the ability toreposition the device 1200 for redeployment or remove the device 1200from the patient.

FIG. 22 is an isometric view of a valve support 1300 in accordance withan embodiment of the present technology. The valve support 1300 can bean embodiment of the valve support 1110 described above with respect toFIGS. 13A-21. The valve support 1300 has an outflow region 1302, aninflow region 1304, a first row 1310 of first hexagonal cells 1312 atthe outflow region 1302, and a second row 1320 of second hexagonal cells1322 at the inflow region 1304. For purposes of illustration, the valvesupport shown in FIG. 22 is inverted compared to the valve support 1110shown in FIGS. 13A-21 such that the blood flows through the valvesupport 1300 in the direction of arrow BF. In mitral valve applications,the valve support 1300 would be positioned within the anchoring member1120 (FIG. 13A) such that the inflow region 1304 would correspond toorientation of the inflow region 1112 in FIG. 13A and the outflow region1302 would correspond to the orientation of the outflow region 1114 inFIG. 13A.

Each of the first hexagonal cells 1312 includes a pair of firstlongitudinal supports 1314, a downstream apex 1315, and an upstream apex1316. Each of the second hexagonal cells 1322 can include a pair ofsecond longitudinal supports 1324, a downstream apex 1325, and anupstream apex 1326. The first and second rows 1310 and 1312 of the firstand second hexagonal cells 1312 and 1322 are directly adjacent to eachother. In the illustrated embodiment, the first longitudinal supports1314 extend directly from the downstream apexes 1325 of the secondhexagonal cells 1322, and the second longitudinal supports 1324 extenddirectly from the upstream apexes 1316 of the first hexagonal cells1312. As a result, the first hexagonal cells 1312 are offset from thesecond hexagonal cells 1322 around the circumference of the valvesupport 1300 by half of the cell width.

In the embodiment illustrated in FIG. 22, the valve support 1300includes a plurality of first struts 1331 at the outflow region 1302, aplurality of second struts 1332 at the inflow region 1304, and aplurality of third struts 1333 between the first and second struts 1331and 1332. Each of the first struts 1331 extends from a downstream end ofthe first longitudinal supports 1314, and pairs of the first struts 1331are connected together to form first downstream V-struts defining thedownstream apexes 1315 of the first hexagonal cells 1312. In a relatedsense, each of the second struts 1332 extends from an upstream end ofthe second longitudinal supports 1324, and pairs of the second struts1332 are connected together to form second upstream V-struts definingthe upstream apexes 1326 of the second hexagonal cells 1322. Each of thethird struts 1333 has a downstream end connected to an upstream end ofthe first longitudinal supports 1314, and each of the third struts 1333has an upstream end connected to a downstream end of one of the secondlongitudinal supports 1324. The downstream ends of the third struts 1333accordingly define a second downstream V-strut arrangement that formsthe downstream apexes 1325 of the second hexagonal cells 1322, and theupstream ends of the third struts 1333 define a first upstream V-strutarrangement that forms the upstream apexes 1316 of the first hexagonalcells 1312. The third struts 1333, therefore, define both the firstupstream V-struts of the first hexagonal cells 1312 and the seconddownstream V-struts of the second hexagonal cells 1322.

The first longitudinal supports 1314 can include a plurality of holes1336 through which sutures can pass to attach a prosthetic valveassembly and/or a sealing member. In the embodiment illustrated in FIG.22, only the first longitudinal supports 1314 have holes 1336. However,in other embodiments the second longitudinal supports 1324 can alsoinclude holes either in addition to or in lieu of the holes 1336 in thefirst longitudinal supports 1314.

FIG. 23 is a side view and FIG. 24 is a bottom isometric view of thevalve support 1300 with a first sealing member 1162 attached to thevalve support 1300 and a prosthetic valve 1150 within the valve support1300. The first sealing member 1162 can be attached to the valve support1300 by a plurality of sutures 1360 coupled to the first longitudinalsupports 1314 and the second longitudinal supports 1324. At least someof the sutures 1360 coupled to the first longitudinal supports 1314 passthrough the holes 1336 to further secure the first sealing member 1162to the valve support 1300.

Referring to FIG. 24, the prosthetic valve 1150 can be attached to thefirst sealing member 1162 and/or the first longitudinal supports 1314 ofthe valve support 1300. For example, the commissure portions of theprosthetic valve 1150 can be aligned with the first longitudinalsupports 1314, and the sutures 1360 can pass through both the commissureportions of the prosthetic valve 1150 and the first sealing member 1162where the commissure portions of the prosthetic valve 1150 are alignedwith a first longitudinal support 1314. The inflow portion of theprosthetic valve 1150 can be sewn to the first sealing member 1162.

The valve support 1300 illustrated in FIGS. 22-24 is expected to be wellsuited for use with the device 1200 described above with reference toFIGS. 18-21. More specifically, the first struts 1331 cooperate with theextended connectors 1210 (FIGS. 18-21) of the device 1200 to separatethe outflow portion of the prosthetic valve 1150 from the capsule 1700(FIGS. 12A and 12B) when the device 1200 is in a partially deployedstate. The first struts 1331, for example, elongate when the valvesupport 1300 is not fully expanded (e.g., at least partially containedwithin the capsule 1700) and foreshorten when the valve support is fullyexpanded. This allows the outflow portion of the prosthetic valve 1150to be spaced further apart from the capsule 1700 in a partially deployedstate so that the prosthetic valve 1150 can at least partially functionwhen the device 1200 (FIGS. 18-21) is in the partially deployed state.Therefore, the valve support 1300 is expected to enhance the ability toassess whether the prosthetic valve 1150 is fully operational in apartially deployed state.

FIGS. 25 and 26 are schematic side views of valve supports 1400 and1500, respectively, in accordance with other embodiments of the presenttechnology. Referring to FIG. 25, the valve support 1400 includes afirst row 1410 of first of hexagonal cells 1412 and a second row 1420 ofsecond hexagonal cells 1422. The valve 1400 can further include a firstrow 1430 of diamond-shaped cells extending from the first hexagonalcells 1412 and a second row 1440 of diamond-shaped cells extending fromthe second hexagonal cells 1422. The additional diamond-shaped cellselongate in the low-profile state, and thus they can further space theprosthetic valve 1150 (shown schematically) apart from a capsule of adelivery device. Referring to FIG. 26, the valve support 1500 includes afirst row 1510 of first hexagonal cells 1512 at an outflow region 1502and a second row 1520 of second hexagonal cells 1522 at an inflow region1504. The valve support 1500 is shaped such that an intermediate region1506 (between the inflow and outflow regions 1502 and 1504) has asmaller cross-sectional area than that of the outflow region 1502 and/orthe inflow region 1504. As such, the first row 1510 of first hexagonalcells 1512 flares outwardly in the downstream direction and the secondrow 1520 of second hexagonal cells 1522 flares outwardly in the upstreamdirection.

Examples

Several aspects of the present technology are set forth in the followingexamples.

1. A system for delivering a prosthetic heart valve device into a heartof a patient, the system comprising:

an elongated catheter body; anda delivery capsule carried by the elongated catheter body and configuredto move between a delivery state for holding the prosthetic heart valvedevice and a deployment state for at least partially deploying theprosthetic heart valve device, wherein the delivery capsule comprises—

-   -   a first housing configured to contain at least a first portion        of the prosthetic heart valve device;    -   a second housing slidably associated with at least a portion of        the first housing, wherein the second housing is configured to        contain a second portion of the prosthetic heart valve device,    -   wherein, during a first deployment stage, the first housing        moves in a distal direction with respect to the second housing        to release the first portion of the prosthetic heart valve        device from the delivery capsule, and wherein, during a second        deployment stage, the second housing and the first housing        together move in a distal direction to release the second        portion of the prosthetic heart valve device from the delivery        capsule.

2. The system of example 1 wherein the delivery capsule furthercomprises:

a first sealing member between a distal portion of the first housing andthe second housing, wherein the first sealing member is slidable alongthe second housing;a second sealing member between a proximal portion of the second housingand the first housing;a first fluid chamber between the first and second sealing members; anda second fluid chamber defined at least in part by an inner surface ofthe second housing,wherein, during the first deployment stage, fluid is delivered to thefirst chamber to slide the first sealing member in the distal directionover the second housing, andwherein, during the second deployment stage, fluid is delivered to thesecond chamber such that the first and second housings move together inthe distal direction.

3. The system of example 2, further comprising a platform extending fromthe elongated catheter body into the second housing, wherein theplatform includes a distal end portion slidably sealed against an innerwall of the second housing and defines a proximal end of the secondfluid chamber.

4. The system of example 2 or 3 wherein the first sealing member is afirst sleeve extending inwardly from the first housing, and the secondsealing member is a second sleeve extending outwardly from the secondhousing.

5. The system of any one of examples 2-4 wherein, after the seconddeployment stage, the first fluid chamber is configured to be evacuatedof fluid while the second fluid chamber remains pressurized with fluidsuch that the first housing moves in a proximal direction.

6. The system of any one of examples 2-5, further comprising:

a first fluid lumen extending through the elongated catheter body and influid communication with the first fluid chamber; anda second fluid lumen extending through the elongated catheter body influid communication with the second fluid chamber.

7. The system of example 6 wherein the first fluid lumen passes throughthe second housing and into a port in the first housing, wherein theport is in fluid communication with the first fluid chamber.

8. The system of example 6 wherein second housing has an inner channelin a wall of the second housing, and wherein the inner channel is influid communication with the first fluid chamber and defines a portionof the first fluid lumen.

9. The system of any one of examples 1-8 wherein the delivery capsulehas an overall length of at most 50 mm.

10. The system of any one of examples 1-9 wherein the delivery capsulehas an overall length of at most 40 mm.

11. The system of any one of examples 1-10 wherein the first housing andthe second housing each have a length of at most 30 mm.

12. The system of any one of examples 1-11, further comprising:

a first spring biasing the first housing toward the delivery state; anda second spring biasing the second housing toward the delivery state.

13. The system of example 1 wherein the second housing includes anarched feature on an outer surface of the second housing and positionedbetween the first and second housings, wherein the system furthercomprises:

-   -   a first tether element attached to a first portion of the first        housing, wherein the first tether element extends from the first        housing, over a distal end portion of the second housing, into        the second housing, and through the elongated catheter body;    -   a second tether element attached to a second portion of the        first housing, wherein the second tether element extends in a        proximal direction around the arched feature, over the distal        end portion of the second housing, into the second housing, and        through though the elongated catheter body,        wherein proximal retraction of the first tether element slides        the first housing over the second housing in the distal        direction to unsheathe at least a portion of the prosthetic        heart valve device from the delivery capsule, and        wherein proximal retraction of the second tether element slides        the first housing over the second housing in a proximal        direction to resheathe the prosthetic heart valve device.

14. A system for delivering a prosthetic heart valve device into a heartof a patient, the system comprising:

an elongated catheter body; anda delivery capsule carried by the elongated catheter body and configuredto be hydraulically driven between a delivery state for holding theprosthetic heart valve device and a deployment state for at leastpartially deploying the prosthetic heart valve device, wherein thedelivery capsule comprises—

-   -   a first housing configured to contain at least a first portion        of the prosthetic heart valve device;    -   a second housing slidably disposed within at least a portion of        the first housing, wherein the second housing is configured to        contain a second portion of the prosthetic heart valve device;    -   a first fluid chamber defined at least in part by an inner        surface of the first housing and an outer surface of the second        housing; and    -   a second fluid chamber defined at least in part by an inner        surface of the second housing,    -   wherein, during a first deployment stage, the first fluid        chamber is configured to receive fluid that moves the first        housing in a distal direction over the second housing to release        the first portion of the prosthetic heart valve device from the        delivery capsule, and    -   wherein, during a second deployment stage, the second chamber is        configured to receive fluid such that the first and second        housings move together in the distal direction to release the        second portion of the prosthetic heart valve device from the        delivery capsule.

15. The system of example 14 wherein the delivery capsule furthercomprises:

a first sealing member between a distal portion of the first housing andthe second housing, wherein the first sealing member is slidable alongthe second housing; anda second sealing member between a proximal portion of the first housingand the second housing,wherein the first fluid chamber extends between the first and secondsealing members.

16. The system of example 14 or 15, further comprising a platformextending from the elongated catheter body into the second housing,wherein the platform includes a distal end portion slidably sealedagainst an inner wall of the second housing, and wherein the distal endportion of the platform defines a proximal end of the second fluidchamber.

17. The system of any one of examples 14-16 wherein, during aresheathing phase, the first fluid chamber is configured to be evacuatedof fluid while the second fluid chamber remains pressurized with fluidto allow the first housing to slide in a proximal direction over thesecond housing.

18. The system of any one of examples 14-17, further comprising:

a first fluid lumen extending through the elongated catheter body and influid communication with the first fluid chamber; anda second fluid lumen extending through the elongated catheter body influid communication with the second fluid chamber.

19. The system of example 18 wherein the first fluid lumen passes intothe second housing, outside the first and second housings, and into aport in the first housing, wherein the port is in fluid communicationwith the first fluid chamber.

20. The system of example 18 wherein the first lumen is defined in partby an inner channel of the second housing.

21. The system of any one of examples 14-20 wherein the first and secondhousings each have a length of 20-30 mm.

22. The system of any one of examples 14-21, further comprising:

a first spring configured to urge the first housing toward the deliverystate when the first fluid chamber is evacuated of fluid; anda second spring configured to urge the second housing toward thedelivery state when the second fluid chamber is evacuated of fluid.

23. A method for delivering a prosthetic heart valve device to a nativemitral valve of a heart of a human patient, the method comprising:

positioning a delivery capsule at a distal portion of an elongatedcatheter body within the heart, the delivery capsule carrying theprosthetic heart valve device;delivering fluid to a first fluid chamber of the delivery capsule toslide a first housing in a distal direction over a portion of a secondhousing, thereby releasing a first portion of the prosthetic heart valvedevice from the delivery capsule; anddelivering fluid to a second fluid chamber of the delivery capsule tomove the second housing together with the first housing in the distaldirection to release a second portion of the prosthetic heart valvedevice from the delivery capsule.

24. The method of example 23, further comprising evacuating fluid fromthe first fluid chamber while the second fluid chamber remainspressurized with fluid such that the first housing slides in a proximaldirection over the second housing.

25. The method of example 23 or 24 wherein positioning the deliverycapsule within the heart comprises delivering the delivery capsuleacross an atrial septum of the heart to a left atrium.

26. A method for delivering a prosthetic heart valve device to a nativemitral valve of a heart of a human patient, the method comprising:

-   -   delivering a delivery capsule at a distal portion of an        elongated catheter body across an atrial septum of the heart to        a left atrium of the heart, the delivery capsule having a first        housing and a second housing slidably disposed within at least a        portion of the first housing, wherein the first and second        housing contain the prosthetic heart valve device in a delivery        state;    -   positioning the delivery capsule between native leaflets of the        native mitral valve;    -   moving the first housing in a distal direction over the second        housing to release a first portion of the prosthetic heart valve        device from the delivery capsule; and    -   moving a second housing in the distal direction to release a        second portion of the prosthetic heart valve device from the        delivery capsule.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example,although steps are presented in a given order, alternative embodimentsmay perform steps in a different order. The various embodimentsdescribed herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

I/We claim:
 1. A method for delivering a prosthetic heart valve deviceto a native valve of a heart of a human patient, the method comprising:positioning a delivery capsule at a distal portion of an elongatedcatheter body within the heart, the delivery capsule carrying theprosthetic heart valve device, wherein the delivery capsule comprises afirst housing configured to contain at least a first portion of theprosthetic heart valve device; and a second housing slidably associatedwith a portion of the first housing, wherein the second housing isconfigured to contain a second portion of the prosthetic heart valvedevice; moving the first housing in a distal direction with respect tothe second housing to release the first portion of the prosthetic heartvalve device from the delivery capsule; and moving the second housingand the first housing together in a distal direction to release thesecond portion of the prosthetic heart valve device from the deliverycapsule.
 2. The method of claim 1, wherein the delivery capsule furthercomprises: a first sealing member between a distal portion of the firsthousing and the second housing, wherein the first sealing member isslidable along the second housing; a second sealing member between aproximal portion of the second housing and the first housing; a firstfluid chamber between the first and second sealing members; and a secondfluid chamber defined at least in part by an inner surface of the secondhousing, wherein moving the first housing in a distal direction withrespect to the second housing comprises delivering a fluid to the firstchamber to slide the first sealing member in the distal direction overthe second housing, and wherein moving the second housing and the firsthousing together in a distal direction fluid comprises delivering fluidto the second chamber such that the first and second housings movetogether in the distal direction.
 3. The method of claim 2, wherein thedelivery capsule further comprises a platform extending from theelongated catheter body into the second housing, wherein the platformincludes a distal end portion slidably sealed against an inner wall ofthe second housing and defines a proximal end of the second fluidchamber.
 4. The method of claim 2, wherein the first sealing member is afirst sleeve extending inwardly from the first housing, and wherein thesecond sealing member is a second sleeve extending outwardly from thesecond housing.
 5. The method of claim 2, further comprising evacuatingthe first fluid from the first fluid chamber while the second fluidchamber remains pressurized with fluid such that the first housing movesin a proximal direction.
 6. The method of claim 2, wherein a first fluidlumen extends through the elongated catheter body and is in fluidcommunication with the first fluid chamber; and wherein a second fluidlumen extends through the elongated catheter body and is in fluidcommunication with the second fluid chamber.
 7. The method of claim 6,wherein the first fluid lumen passes through the second housing and intoa port in the first housing, and wherein the port is in fluidcommunication with the first fluid chamber.
 8. The method of claim 6,wherein the second housing comprises an inner channel in a wall of thesecond housing, and wherein the inner channel is in fluid communicationwith the first fluid chamber and defines a portion of the first fluidlumen.
 9. The method of claim 1, wherein the delivery capsule has anoverall length of at most 50 mm.
 10. The method of claim 1, wherein thedelivery capsule has an overall length of at most 40 mm.
 11. The methodof claim 1, wherein the first housing and the second housing each have alength of at most 30 mm.
 12. The method of claim 1, wherein a firstspring biases the first housing toward a delivery state, and wherein asecond spring biasing the second housing toward the delivery state. 13.The method of claim 1, wherein the second housing includes an archedfeature on an outer surface of the second housing and positioned betweenthe first and second housings, wherein a first tether element attachesto a first portion of the first housing, wherein the first tetherelement extends from the first housing, over a distal end portion of thesecond housing, into the second housing, and through the elongatedcatheter body, wherein a second tether element attached to a secondportion of the first housing, wherein the second tether element extendsin a proximal direction around the arched feature, over the distal endportion of the second housing, into the second housing, and throughthough the elongated catheter body, the method further comprising:proximally retracting of the first tether element to slide the firsthousing over the second housing in the distal direction to unsheathe atleast a portion of the prosthetic heart valve device from the deliverycapsule, and proximally retracting of the second tether element to slidethe first housing over the second housing in a proximal direction toresheathe the prosthetic heart valve device.
 14. A method for deliveringa prosthetic heart valve device to a native valve of a heart of a humanpatient, the method comprising: positioning a delivery capsule at adistal portion of an elongated catheter body within the heart, thedelivery capsule carrying the prosthetic heart valve device; deliveringfluid to a first fluid chamber of the delivery capsule to slide a firsthousing in a distal direction over a portion of a second housing so thata first portion of the prosthetic heart valve device is released fromthe delivery capsule; and delivering fluid to a second fluid chamber ofthe delivery capsule to move the second housing together with the firsthousing in the distal direction to release a second portion of theprosthetic heart valve device from the delivery capsule.
 15. The methodof claim 14, further comprising evacuating fluid from the first fluidchamber while the second fluid chamber remains pressurized with fluidsuch that the first housing slides in a proximal direction over thesecond housing.
 16. The method of claim 14, wherein positioning thedelivery capsule within the heart comprises delivering the deliverycapsule across an atrial septum of the heart to a left atrium.
 17. Themethod of claim 14, wherein a first sealing member is between a distalportion of the first housing and the second housing, wherein the firstsealing member is slidable along the second housing, wherein a secondsealing member is between a proximal portion of the first housing andthe second housing, and wherein the first fluid chamber extends betweenthe first and second sealing members.
 18. The method of claim 14,wherein the first and second housings each have a length of 20-30 mm.19. The method of claim 14, wherein a first spring is configured to urgethe first housing toward a delivery state when the first fluid chamberis evacuated of fluid, and wherein a second spring configured to urgethe second housing toward the delivery state when the second fluidchamber is evacuated of fluid.
 20. A method for delivering a prostheticheart valve device to a native mitral valve of a heart of a humanpatient, the method comprising: delivering a delivery capsule at adistal portion of an elongated catheter body across an atrial septum ofthe heart to a left atrium of the heart, the delivery capsule having afirst housing and a second housing slidably disposed within at least aportion of the first housing, wherein the first and second housingcontain the prosthetic heart valve device in a delivery state;positioning the delivery capsule between native leaflets of the nativemitral valve; moving the first housing in a distal direction over thesecond housing to release a first portion of the prosthetic heart valvedevice from the delivery capsule; and moving a second housing in thedistal direction to release a second portion of the prosthetic heartvalve device from the delivery capsule.